Guidance biological products. Medical search. Frequent questions

The FDA has announced the withdrawal of the proposed rule on "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products," published in the Federal Register of Nov. 13, 2013. (foodengineeringmag.com)

This guidance describes FDA's current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name 2 that includes an FDA-designated suffix. (fda.gov)
Under FDA's Draft Naming Guidance, a biological product licensed under the Public Health Service Act would have to carry a nonproprietary name that includes a unique, FDA-designated suffix. (biosimilarscme.org)
This guidance established a mandatory requirement for electronic submission of certain applications, amendments, supplements, and reports to the FDA's Center for Biologics Evaluation and Research (CBER). (premier-research.com)
For more detailed information, see FDA's guidance titled Information Sheet Guidance For Sponsors, Clinical Investigators, and IRBs - Waiver of IRB Requirements for Drug and Biological Product Studies . (cdc.gov)
As explained in the Good Guidance Practices Final Rule, guidance documents issued by the Food and Drug Administration ("FDA") will be subject to the requirements of the Final Rule until the Secretary amends FDA's existing good guidance practices regulation. (hhs.gov)
These exemptions will be incorporated into the FDA's amendments to its good guidance practices regulation. (hhs.gov)
The participant will gain insight into the FDA's Office of Generic Drugs, and how their research supports guidance development and regulatory decision making, as part of the Generic Drug User Fee Amendments (GDUFA) Program. (joinhandshake.com)
The final guidance does not vary significantly from the draft, and it provides not only useful information for industry on how to submit a request and what to include, but also sets forth FDA's intent to respond within 60 days and describes the internal review process. (agg.com)
A spokeswoman for the FDA emailed a statement that, "If they (patient-matched devices) include biologics or living cells (combination products) or consist entirely of biological (cellular and tissue-based), they would be reviewed within the FDA's Center for Biologics Evaluation and Research. (sme.org)
Also, the FDA's 2017 "Technical Guidance for Additive Manufactured Devices" addresses patient confidentiality, process validation and other issues relative to bioprinting. (sme.org)

This session was recorded as part of FDLI's Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in October 2023. (fdli.org)
The Health Assembly is invited to note the draft road map for access to medicines, vaccines and other health products, 2019-2023, as contained in the Annex. (who.int)
To meet this PDUFA VII commitment, FDA issued its Framework for the Use of Digital Health Technologies in Drug and Biological Product Development in late March 2023. (clinicalleader.com)

First, FDA released a notice announcing the availability of draft guidance entitled "Nonproprietary Naming of Biological Products. (healthindustrywashingtonwatch.com)
Specifically, the draft guidance proposes that reference biologics and biosimilars will have nonproprietary names that share a core substance name but are distinguished from each other with a unique four-lowercase letter suffix that FDA will assign at random, with no meaning attached. (healthindustrywashingtonwatch.com)
Comments to the draft guidance are due to FDA on or before October 27, 2015 and can be submitted here . (healthindustrywashingtonwatch.com)
Alongside the draft guidance, FDA issued a proposed rule designating official names for six specific biological products. (healthindustrywashingtonwatch.com)
The names of these products would include distinguishing suffixes composed of four lowercase letters in accordance with the draft guidance. (healthindustrywashingtonwatch.com)
In March 2019, the FDA released draft guidance on the design and implementation of natural history studies to support the development of safe and effective treatments for rare diseases. (premier-research.com)
The FDA has released a new draft guidance for sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for the treatment of specific hematologic malignancies. (premier-research.com)
New direction is contained in two new agency draft guidance documents recently published by the agency. (premier-research.com)
The FDA issued a draft guidance on regulations for human subjects protections for children, stating the Additional Safeguards for Children in Clinical Investigations (21 CFR 50, subpart D), must be considered when children are enrolled in a clinical trial. (uwosh.edu)

This guidance also provides guidance on cleaning, disinfection, and waste disposal procedures during flight. (cdc.gov)
ISO 14161:2009 provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. (iso.org)
This document provides guidance to sponsors planning to file applications for new uses of marketed drug and biological products for the treatment of cancer. (fda.gov)
The Office of Financial Aid provides guidance on applying for financial aid or FAFSA, information on scholarships and loan repayment options. (unmc.edu)
The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. (westpharma.com)
This report provides the updated recommendations, summarizes the safety and effectiveness data considered by ACIP, and provides guidance for implementing the recommendations. (cdc.gov)

citation needed] In March 2020, most protein products that were approved as drug products (including every insulin currently on the market as of December 2019[update]) are scheduled to open up to biosimilar and interchangeable competition in the United States. (wikipedia.org)

Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. (wikipedia.org)
The FDA gained the authority to approve biosimilars (including interchangeables that are substitutable with their reference product) as part of the Patient Protection and Affordable Care Act signed into law by President Obama on March 23, 2010. (wikipedia.org)
On August 28, 2015 the federal Food and Drug Administration ("FDA") issued two important policies regarding naming biological products, including biosimilars. (healthindustrywashingtonwatch.com)
Biosimilars or similar biotherapeutic products are the biological products approved by regulatory agencies based on the demonstration of similarity in quality, safety and efficacy with reference biologics (or original biologics). (lww.com)
Though biosimilars could be considered as interchangeable therapeutic alternatives over original biologics, there are concerns regarding their similarity in effectiveness and safety with reference product along with the level of evidence of similarity required for approval. (lww.com)
The current WHO EML includes a statement regarding "including quality-assured biosimilars" as potential alternatives for certain products on the EML (i.e., adalimumab, pegaspargase, rituximab, trastuzumab). (ifpma.org)
Finally, good practice established in support of switching between biosimilars (SBPs) and their reference medicinal product always includes guidance for the prescriber and a recognition that any switching between alternatives of a biological medicine should be supervised by the healthcare professional and with full knowledge and awareness of the patient. (ifpma.org)
Biosimilars are as effective and safe as originator biological therapies for patients with inflammatory bowel disease (IBD), according to new data. (medscape.com)
Nine of the reviewed studies compared patients who continued taking the originator product with patients who had switched to biosimilars. (medscape.com)

This is the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was passed as part of the Affordable Healthcare Act. (wikipedia.org)
Biologics are biotechnology-derived medicinal products manufactured from living organisms or contain components of living organisms, and these products are specifically designed to resemble the body proteins or modulate the immune system. (lww.com)
They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (devices, drugs, and biologics). (clinicalleader.com)
1This guidance has been prepared by the Epidemiology Branch in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. (cdc.gov)

In October 2018, the Food and Drug Administration (FDA) issued Standard Operating Policy and Procedure (SOPP) - SOPP 8214 Version 1.0: INTERACT Meetings with Sponsors for Drugs and Biological Products. (premier-research.com)
As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. (joinhandshake.com)
Recognizing this gap, in its most recent Prescription Drug User Fee Act (PDUFA VII) commitment letter, FDA agreed to establish "a DHT framework document [to] guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products. (clinicalleader.com)

Biological products have made a major transformation in the therapeutics of many diseases, particularly for chronic diseases involving overactive immune system or impaired immune surveillance 1 2 . (lww.com)
Living guidance Therapeutics and COVID- biological medical products. (who.int)

citation needed] The World Health Organization (WHO) published its "Guidelines for the evaluation of similar biotherapeutic products (SBPs)" in 2009. (wikipedia.org)

According to FDA, the guidance is meant to clearly identify biological products to improve pharmacovigilance, and for the purpose of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. (healthindustrywashingtonwatch.com)
This is meant to improve pharmacovigilance and reduce substitution of biological products that are not interchangeable. (biosimilarscme.org)

Drug-related authorities such as the European Medicines Agency (EMA) of the European Union, the United States Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. (wikipedia.org)
They are biological agents that are highly similar to the original biologic compound in their structure, biological activity, efficacy and safety. (smw.ch)
This may result in potency loss, altered efficacy and adverse biological effects. (westpharma.com)
Given the WHO's commitment to supporting globally acceptable principles for licensing biological products that are claimed to be similar to biological products of assured quality, safety, and efficacy on the basis of proven similarity, along with the large number of noncomparable biotherapeutics globally, the WHO should define what constitutes a quality-assured biosimilar. (ifpma.org)
It is now possible to evaluate the efficacy of aerosolized products intended to reduce or eliminate indoor airborne organisms in large indoor spaces such as arenas, hospitals, schools, transportation, and more. (element.com)
Prepare for the imminent release of EPA guidance for the efficacy of air treatments for public health claims, expected as early as the end of 2022. (element.com)

On December 3, 2020, HHS released a Final Rule governing the agency's release and maintenance of guidance documents. (hhs.gov)

On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz. (wikipedia.org)

Since 2017, Deloitte's real-world evidence (RWE) benchmarking studies have signaled the biopharmaceutical industry's efforts to expand the use of real-world data (RWD) and RWE across the product life cycle. (deloitte.com)

The European Medicines Agency has updated its guidance on the parallel distribution of medicinal products. (rssl.com)
Parallel distribution' refers to Centrally Authorised medicinal Products ('CAPs') put on the market of one member state that can be marketed in any other member state by a distributor, independently of the marketing-authorisation holder. (rssl.com)
The European Medicines Agency has updated its guidance on biological medicinal products (which takes the form of a 'Q&A' document). (rssl.com)

The FDA continues to facilitate efforts to keep drug product labeling up to date throughout the product lifecycle. (foodengineeringmag.com)
The withdrawal doesn't alter the obligation for holders of marketing applications for drug and biological products to ensure labeling is not misleading. (foodengineeringmag.com)
citation needed] The FDA has previously approved biologic products using comparability, for example, Omnitrope in May 2006, but this like Enoxaparin was also to a reference product, Genotropin, originally approved as a biologic drug under the FD&C Act. (wikipedia.org)
Cloning of human genetic material and development of in vitro biological production systems has allowed the production of virtually any recombinant DNA based biological substance for eventual development of a drug. (wikipedia.org)
The staff of the Federal Trade Commission's (FTC's) Office of Policy Planning, Bureau of Economics, and Bureau of Competition suggests that the Food and Drug Administration (FDA) reconsider a proposal for nonproprietary names of biologic products. (biosimilarscme.org)
This guidance for industry is part of ongoing Agency efforts to encourage the submission of supplemental applications for new uses for approved drug and biological products. (fda.gov)
The guidance also is consistent with section 403 of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act), which specifies that the FDA will continue its efforts to encourage sponsors to submit supplemental applications for new uses for their products. (fda.gov)
Current perspectives on stability of protein drug products during formulation, fill and finish operations. (smw.ch)
This is essential to enable customers to pair new and more complex drug products with the right containment systems, delivery systems and combination products - and navigate the challenging, and ever-changing, regulatory environments. (westpharma.com)
We have established expert-level skill in critical areas and industry regulations, as well as state-of-the art testing capabilities to ensure that West is uniquely positioned to partner with customers across the globe to design, execute and interpret studies needed to help drug products and associated packaging and delivery systems move efficiently and safely to patients. (westpharma.com)
The guidance focuses on applying HFE principles for medical devices combined with a drug or biological product. (packagingdigest.com)
In response to the newly released U.S. Food and Drug Administration (FDA) guidance on COVID-19, the Statistics Department at Premier Research has committed to highlighting specific and necessary actionable considerations that directly address key FDA recommendations in the guidance. (premier-research.com)
This program provides training in the basic principles of clinical research - analyzing data, interpreting medical literature, and communicating results - and the overall management of clinical drug, biological, and medical device trials. (fdu.edu)
FDA has obtained two exemptions from the Director of the Office of Management and Budget that exempt the following types of guidance documents from the requirement that they be posted to the guidance repository: (1) Product-Specific Guidances for Generic Drug Development, and (2) Mammography Quality Standards Act (MQSA) Policy Guidance Help System (PGHS). (hhs.gov)
This project explores knowledge management systems for FDA-funded scientific research, CDER approved drug products, CDER published guidance including product-specific guidance, as well as the refinement of processes and infrastructure to analyze and track how research outcomes from FDA-funded scientific research can be used to support product-specific guidance development. (joinhandshake.com)
3 While neither a legally binding document nor an agency guidance, the framework represents the agency's road map for developing an approach to the use of DHTs in regulatory decision-making related to drug and biological product development. (clinicalleader.com)
Drug developers who are using or intend to use DHTs in their product development activities should pay close attention to this framework and opportunities to engage with FDA as it crafts its regulatory agenda. (clinicalleader.com)
The framework details the agency's plan to effectively identify and address the challenges with the use of DHT in drug and biological product development, encompassing the agency's internal efforts as well as engagement with external stakeholders. (clinicalleader.com)
The Food and Drug Administration (FDA) believes that the recommendations in this guidance document will improve the quality of postmarketing safety reports and clarify the industry's current safety reporting responsibility to assure public health. (cdc.gov)
Earlier this month, the Office of Combination Products of the Food and Drug Administration issued a final guidance for industry, How to Prepare a Pre-Request for Designation (Pre-RFD) . (agg.com)
This book provides succinct and practical guidance on how to develop a biological drug product and, at the same time, stay within the regulatory expectations at each phase of the development process! (pda.org)
In lieu of guidance, US Food and Drug Administration (FDA) regulators have authored publications and presentations describing regulator expectations. (bvsalud.org)
The intended drug product usage may involve the dilution of drug formulation into admixtures for infusion and exposure to new interfaces of administration components like intravenous (iv) bags, syringes, and tubing. (bvsalud.org)
In-use studies assess the potential impact on product quality by simulating drug handling throughout the defined in-use period. (bvsalud.org)
The insights compiled in this review article can be leveraged across the industry and encompass topics such as representative drug product material and administration components, testing conditions, quality attributes evaluated and respective acceptance criteria, applied quality standards, and regulatory requirements. (bvsalud.org)
Food and Drug Administration Guidance on Design of Clinical Trials for Gene Therapy Products with Potential for Genome Integration or Genome Editing and Associated Long-Term Follow-Up of Research Subjects. (cdc.gov)

If and how the collaboration across product centers evolves will be critical to operationalizing the framework and to achieving the agency's DHT goals more generally. (clinicalleader.com)
This guidance represents the Agency's current thinking on reporting of certain postmarketing adverse experiences for licensed vaccines. (cdc.gov)

The draft report was updated based on the feedback obtained by these consultation processes, including broadening of the scope to include medicines, vaccines and health products. (who.int)
A plethora of biological agents are currently available in the market, including insulins, vaccines, human growth hormone, erythropoietin, interleukins, interferon, clotting factors and monoclonal antibodies 3 4 . (lww.com)
Do not use this form to propose a name for a biological substance to be used in complementary medicines, vaccines, peptides, monoclonal antibodies and other recombinant products. (tga.gov.au)
He has a Ph.D. in Peptide Chemistry and has extensive expertise in aseptic processing and a wide range of unique and unusual biotechnology processes, including live vaccines, tissue culture products, and cellbased products, working with many of the top 20 Global Pharma and Biopharma companies. (pda.org)

Some of the most significant elements to build into the product's design, manufacturing and distribution processes are product marking and traceability procedures that are used before manufacture, during manufacture, and during distribution. (incompliancemag.com)
The goal of this RFA is to stimulate the development of a new generation of methods for natural products chemistry, and in doing so, to reinvigorate the investigation of nature as a prolific source of small-molecules with the potential to interact with all of the proteins that participate in cellular processes in health and disease. (nih.gov)
Are you developing innovative processes or products, undertaking experimentation or solving technological problems? (grantthornton.ca)

It also describes specific steps FDA is taking to foster the updating of labeling for products used in cancer treatment. (fda.gov)
Such guidance should be outlined in any guidance that describes the basis for alternatives for biological treatment. (ifpma.org)
The Guidance describes the type of basic information that a Pre-RFD should contain and includes a checklist. (agg.com)

For example, the nonproprietary name of a reference product could be bioproduct-dkmy and a biosimilar of that product could be bioproduct-fzbs. (healthindustrywashingtonwatch.com)
With respect to interchangeable biological products, FDA is soliciting comments on whether the nonproprietary name for such a product should include a distinct suffix, or should share the same suffix as its reference product. (healthindustrywashingtonwatch.com)

Define the core considerations necessary to establish biological guidance values (BGVs) for application in the public health contexts. (cefic-lri.org)

This guidance for industry discusses the quality and quantity of data that may be adequate to add a new use to the prescribing information for a product used in the treatment of cancer. (fda.gov)
The framework would then be used to stimulate broader discussion and to help focus and direct supporting industry product stewardship activities. (cefic-lri.org)
The increasing number of products placed on the EML demonstrates the critical role played by the biopharmaceutical industry in creating therapies that are safe, efficacious and essential in reaching the UN Sustainable Development Goals, chief amongst them achieving universal health coverage. (ifpma.org)
To get more information about the recommendations for blood establishments collecting blood and blood components please see the complete Guidance for Industry Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components . (gmp-compliance.org)
Digital health technology (DHT) is increasingly permeating the medical products industry due to its use in general wellness applications, medical devices intended to diagnose, treat, or prevent disease, and as a tool in clinical research. (clinicalleader.com)
This guidance for industry has been developed to clarify what information should be obtained before an individual case of an adverse experience after immunization should be submitted to the Vaccine Adverse Event Reporting System (VAERS). (cdc.gov)
The executive order exerts oversight over safety tests that companies use to evaluate conversation bots such as ChatGPT and introduces industry standards like watermarks for identifying AI-fueled products, among other regulations. (yahoo.com)
The executive order lays out a sprawling set of industry standards in the hope of creating transparent products secure from dangerous outcomes, such as AI-concocted biological material or cyberattacks. (yahoo.com)
The industry guidance will function as suggestions rather than mandates, leaving firms free to set aside the government recommendations. (yahoo.com)
The working group assessed regulatory guidance, current industry practice via a blinded survey of IQ Consortium member companies, and scientific rationale to align on recommendations for experimental design, execution of microbial challenge in-use studies, and a decision tree for microbial data interpretation to assign in-use hold times. (bvsalud.org)
The recommendations provided in this manuscript will help streamline biological product development, ensure consistency on assignment of in-use hold times in biological product labels across industry, and provide maximum allowable flexibility to HCPs and patients, while ensuring patient safety. (bvsalud.org)
A working group reviewed and consolidated industry approaches to assess physicochemical stability of traditional protein-based biological products during clinical development and for commercial use. (bvsalud.org)

whether CBER, CDER, or CDRH will regulate the product if it is not a combination product, or which of the centers will have primary jurisdiction if it is a combination product. (agg.com)

The "2014 Interim Guidance on Patent Subject Matter Eligibility" was published by the United States Patent and Trademark Office (USPTO) on Dec. 16 ( see this alert pertaining to Alice Corp . and software implemented inventions). (btlaw.com)

But Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. (wikipedia.org)
And under the BPCI Act, only a biologic that has been approved as an "interchangeable" may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. (wikipedia.org)
However, "chemically synthesized polypeptides" are excluded from this transition, which means that a product that falls within this category won't be able to come to market as a biosimilar or interchangeable product, but will have to come to the market under a different pathway. (wikipedia.org)

The Biologicals Framework covers blood, blood components, tissue & cellular products, tissue & cell based derivatives and other emerging biological therapies. (tga.gov.au)

EMA revises Guidance on Development, Production, Characterization and Specification for Monoclonal Antibodies and related Products. (gmp-compliance.org)

It's already been three years since the FDA issued its "Guidance on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. (premier-research.com)

The Evaluation for SARS-CoV-2 Testing in Animals guidance document was added into this document. (cdc.gov)

The FDA has issued numerous guidances on topics related to the regulation of such technologies as medical devices. (clinicalleader.com)

The CBER recognised these documents for their guidances and implemented them as consistent with the FDA requirements and recommendations. (gmp-compliance.org)

Synthetic biology is an emerging interdisciplinary field of biotechnology that involves applying the principles of engineering and chemical design to biological systems. (cdc.gov)
Another rule would ensure that biotechnology firms take appropriate precautions when using AI to create or manipulate biological material. (yahoo.com)
With the right ethical guidance, biotechnology could revolutionize the way we manufacture things, making use of the beauty and efficiency of biological growth. (jorislaarman.com)

The EPO has at some points appeared to "firmly" establish that plants and plant materials that have been obtained by an unpatentable essentially biological process are patentable and at other times that they are not patentable 3 . (cooley.com)
Establish, maintain, and grow market share with air treatment products that have been validated by Element to provide public health improvements. (element.com)
The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts. (hhs.gov)

Moreover, any measure to switch between biological products implies additional requirements in identification and recording in patient notes to ensure product traceability. (ifpma.org)
Of course, in the event of a recall, this traceability will allow the manufacturer of the finished product or component part to narrow the affected population and more easily identify the affected population of customers. (incompliancemag.com)

and (4) testing for packaging, devices and combination products. (westpharma.com)
For testing, the capability to conform to critical ISO methods (e.g., 11040-8 Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes and 11608-1 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers) has been established - critical to assist customers to properly evaluate performance of container/delivery/combination products. (westpharma.com)

Additionally, Bacillus anthracis has always been high on the list of potential agents with respect to biological warfare and bioterrorism, having been used in that context on at least two occasions. (who.int)

Equitable access to health products is a global priority, and the availability, accessibility, acceptability, and affordability of health products of assured quality need to be addressed in order to achieve the Sustainable Development Goals, in particular target 3.8.1 Every disease management strategy requires access to health products for prevention, diagnosis, treatment, palliative care and rehabilitation. (who.int)
User-based research, enhanced visual elements, and early co-development of product and packaging support IFU designs for medical devices. (packagingdigest.com)
Accordingly, most products in development today will never see 10,000 to 20,000 liter bioreactors. (genengnews.com)
Among the promised duties for this yet-to-be-filled body of 16 patient community representatives: Propose new collaboration models in which patients and patient advocates are partners in healthcare product development and U.S. Food. (premier-research.com)
The Institutes and Centers (ICs) of the NIH invite applications for funding from the NIH Molecular Libraries Roadmap program for the development of novel methodologies related to natural products chemistry. (nih.gov)
10 While plans to harmonize guidelines/standards across product centers to facilitate and increase the use of DHTs in product development is a noble goal, implementation could be a challenge. (clinicalleader.com)

On the subject of integration and "complete solutions," GE Healthcare's ReadyToProcess™ product line covers all unit operations from media preparation and cell cultivation to protein purification. (genengnews.com)

Inspired by groundbreaking works that balance on the edge of arts and genomics, the motivation behind this project is to study in vitro manufacturable products in collaboration with scientists, artists and designers. (jorislaarman.com)

However, FDA indicates that the Agency is also considering, and seeks feedback on, an alternative nonproprietary naming format for biological products in which the suffix attached to the core name would be derived from the name of the license holder listed on the license. (healthindustrywashingtonwatch.com)

This guidance addresses the event of a commercial passenger aircraft traveler exhibiting symptoms consistent with Ebola disease or another viral hemorrhagic fever (VHF, e.g. (cdc.gov)

Please refer to Proposed Approved Biological Name (ABN) application form to propose a name for a biological substance. (tga.gov.au)

Hazard characterization the best features of existing guidance, frameworks, and models using a weight-of-evidence (WoE) approach. (cdc.gov)

In this manual, the World Health Organization (WHO) updates its guidance for governments in preparing for a possible terrorist attack with biological or chemical weapons. (cdc.gov)
Descriptions of the sarin attack in Tokyo in 1995 and the anthrax attacks in the United States in 2001 illustrate lessons from governments' recent experiences with chemical and biological terrorism. (cdc.gov)
This manual will find a home on bookshelves worldwide among government officials and others concerned about the threat of biological and chemical terrorism. (cdc.gov)
But the book's underlying theme-that public health preparedness for biological or chemical terrorism depends on fundamental capacities to respond to more common health threats-is its most salient message, no matter where the user resides. (cdc.gov)
chemical derivatization of natural products [Note that throughout this RFA, the term "natural product" refers to a single, well-defined chemical compound, as opposed to a mixture or extract, obtained from a living organism. (nih.gov)
Chemical, biological, radiological and nuclear hazards are dangerous and can be life-threatening to local communities and people who work in the area. (fema.gov)
Chemical, biological, radiological and nuclear (CBRN) data sharing network, key planning factors, interactive web tools and regional support. (fema.gov)

Guidance Document Authorisation Biosimilar. (smw.ch)

This guidance does not relieve any person of the obligation to comply with all applicable Federal Aviation Administration (FAA) regulations for issues related to the aircraft and Occupational Safety and Health Administration (OSHA) regulations for those workers conducting the decontamination of the aircraft or handling and disposing waste. (cdc.gov)
Shipping liquids internationally can be tricky, but as long as you're aware of the various regulations and take some precautions when packing and labelling your shipment, you'll be able to get your products where they need to go without any problems. (dhl.com)
These regulations will help to ensure that the public receives appropriate notice of new guidance and that the Department's guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them. (hhs.gov)

Content will not include any discussion of the unlabeled use of a product or a product under investigational use. (cdc.gov)

We have collected reports of adverse reactions to health products in Canada since 1965. (canada.ca)
For marketed health products, these reports are known as adverse reaction or medical device incident reports. (canada.ca)
They must provide Health Canada with safety information, including adverse reaction and medical device incident reports, about the products they are responsible for in Canada. (canada.ca)
Adverse reaction reports and medical device incidents provide information on events suspected to be related to a health product. (canada.ca)
Results for loss of response, treatment cessation, and serious adverse events were similar between patients who continued the originator product and those who switched. (medscape.com)

The Guidance states that OCP's review will include involvement of the relevant centers, and, as necessary, the Office of Chief Counsel. (agg.com)

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. (wikipedia.org)
Bookmark this list of US and international agencies for questions, concerns, and guidance on medical devices and combination. (packagingdigest.com)
Real-world evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. (deloitte.com)
DHTs may also be used to develop or study medical products. (clinicalleader.com)

Composed of international leaders in the field of microbial-pathogenic threat analysis, mitigation, response and recovery, GBAC provides training, guidance, accreditation, certification, crisis management assistance and leadership to government, commercial and private entities looking to mitigate, quickly address and/or recover from biological threats and real-time crises. (dfwairport.com)

Reference to the innovator product is an integral component of the approval. (wikipedia.org)

Anatomy2

Diseases1

Chemicals and Drugs7

Analytical, Diagnostic and Therapeutic Techniques and Equipment7

Phenomena and Processes3

Disciplines and Occupations1

Anthropology, Education, Sociology and Social Phenomena3

Technology, Industry, Agriculture3

Information Science3

Health Care6

Geographicals1

Approved Drugs and Biological Products1

FDA's10

20233

Draft guidance9

Provides guidance6

20191

Biosimilars9

Biologics4

Drugs3

Therapeutics2

Similar biotherapeutic products1

Pharmacovigilance2

Efficacy6

Governing the agency's1

Biosimilar product1

20171

Medicinal3

Drug26

Agency's2

Vaccines4

Processes3

Describes3

Nonproprietary name2

Considerations1

Industry12

CDER1

Interim Guidance1

Interchangeable3

Therapies1

Monoclonal Antibodies1

Pharmaceutical1

Evaluation1

Regulation1

CBER1

Biotechnology3

Establish3

Traceability2

Combination products2

Respect to biological1

Development6

Protein1

Vitro1

Suffix1

Consistent1

Substance1

Characterization1

Chemical7

DOCUMENT1

Regulations3

Investigational1

Adverse5

Centers1

Medical4

Threats1

Innovator1