System product surveillance postmarketing. Medical search. Frequent questions

Any person having a biologics license under Sec. 601.20 of this chapter shall promptly review all adverse experience information pertaining to its product obtained or otherwise received by the licensed manufacturer from any source, foreign or domestic, including information derived from commercial marketing experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies, reports in the scientific literature, and unpublished scientific papers. (cdc.gov)

Here, we present a thorough descriptive analysis of reports to a national passive vaccine safety surveillance system (VAERS) of myopericarditis after vaccines licensed for use in the United States. (cdc.gov)
RePub, Erasmus University Repository: Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: Why and how? (eur.nl)
Overall, the combination of multiple healthcare databases increases statistical sample size and heterogeneity of exposure for postmarketing drug and vaccine safety surveillance, despite posing several technical challenges. (eur.nl)

With respect to regulation, two terms are defined: Postmarketing requirements are studies and clinical trials that sponsors are required to conduct and postmarketing commitments are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statue or regulation. (wikipedia.org)
Manufacturers were asked to conduct similar analyses of their postmarketing surveillance databases. (aap.org)
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. (complianceonline.com)
The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA identifying clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug studies with human investigational drugs. (pagefreezer.com)
EU-ADR, Sentinel, OMOP, PROTECT and VAESCO) are based on the combined use of multiple healthcare databases for the conduct of active surveillance studies in the area of drug and vaccine safety. (eur.nl)
The aim of this review is to provide a summary of the potential, disadvantages, methodological issues and possible solutions concerning the conduct of postmarketing multidatabase drug and vaccine safety studies, as demonstrated by several international initiatives. (eur.nl)

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) jointly operate the Yellow Card Scheme, which was one of the first examples of a pharmacovigilance scheme, aimed at mitigating adverse drug reactions (ADRs). (wikipedia.org)
The monitoring and analysis of the severity of ADRs is limited by the current qualitative and categorical systems of severity classification. (jmir.org)
Ocular ADRs are frequent and the majority of these events are innocuous for the patients, although detrimental reactions, including fatal ADRs and blindness, have been reported and need to be effectively prevented to safeguard patients and reduce strain on the health system. (smw.ch)

Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. (wikipedia.org)
The Division of Pharmacovigilance at the US Food and Drug Administration (FDA) recently reviewed postmarketing cases of DRESS reported in association with the use of ziprasidone in the FDA Adverse Event Reporting System (FAERS). (psychiatrist.com)
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), described Sentinel as one element in a broader FDA effort to encourage safe use of medications, revamp the agency's pharmacovigilance system, explore the use of social media to publicize safety issues, and better understand drug effects in different populations through worldwide collaborations. (pharmexec.com)
The manufacture of increasingly complex medical products also requires stronger surveillance and oversight, yet many NRAs have insufficient capacity in post-marketing surveillance or pharmacovigilance. (paho.org)
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. (who.int)
Post-marketing surveillance and pharmacovigilance is a potential weakness of systems. (paho.org)

It has been estimated that AEs cost the health-care system several billion dollars due to excess morbidity and mortality. (mhmedical.com)

FAERS supports FDA postmarketing safety surveillance for drug and therapeutic biologic products. (psychiatrist.com)
To this end, FDA is centralizing adverse event (AE) analysis through an all-FDA Adverse Event Reporting Systems (FAERS), and is creating a MedWatch Plus single portal for public AE reporting. (pharmexec.com)
The FDA Adverse Event Reporting System (FAERS) database contains information on adverse event and medication error reports submitted to FDA. (pagefreezer.com)

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)
The Executive Board is invited to consider the draft road map for access to medicines, vaccines and other health products, 2019-2023, as contained in the Annex, and to provide further guidance as appropriate. (who.int)
2 In line with resolution WHA69.19 (2016) on the global strategy on human resources for health: workforce 2030, a health workforce impact assessment was carried out for the draft road map for access to medicines, vaccines and other health products, 2019-2023 (se e https://www.who.int/hrh/documents/B144_HRH-links_160119-EMP.pdf, accessed 16 January 2019). (who.int)
COVID-19 has imposed additional barriers to access to medicines and vaccines, including the impact of lockdowns on the supply chain which led to shortages of medical products and increases in price. (who.int)
This paper presents a new regional strategy for the Eastern Mediterranean Region which has been developed to address the barriers to accessing medicines and vaccines, and to guide countries in strengthening their national health systems over the next 10 years. (who.int)
It advances eight strategic objectives related to: updating and implementing national policies for medicines and vaccines ecuring adequate and sustainable funding nsuring the availability of medicines and vaccines at fair and affordable prices stablishing efficient supply systems trengthening national regulatory authorities ensuring appropriate use of medicines romoting research and development as well as local production establishing a strong partnership framework. (who.int)
Content will not include any discussion of the unlabeled use of a product or product under investigational use with the exception of Dr. Lisa Grohskopf's discussion of FDA-approved package inserts for egg-based influenza vaccines that indicate that their use is contraindicated for people who have had a severe allergic reaction to any vaccine component which includes egg for egg-based vaccine. (cdc.gov)

To discuss the issue of postapproval monitoring of newly approved agents, Medscape spoke with Gerald Dal Pan, MD, MHS, director of the Office of Surveillance and Epidemiology at the FDA's Center for Drug Evaluation and Research, about the postmarket approval process and its implications for clinicians prescribing newly approved agents. (medscape.com)

refers also to available legislation, guidance for appropriate test methods for measuring traces, key principles for overall risk assessment in AHP products and takes into account consumer exposure. (edana.org)
This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do, and a key element is a thorough risk assessment. (complianceonline.com)
We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately. (complianceonline.com)

Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. (wikipedia.org)
Post-marketing surveillance of these medications should include collaboration between FDA and the product manufacturer and should be supported by information reported by pharmacists and patients to an established surveillance system, such as MedWatch. (ashp.org)
These are reports describing an adverse event that took place while using a medicine which people at the point of care send either to the drug's manufacturer or to the FDA using our MedWatch system. (medscape.com)

Washington D.C. 29 September 2022 (PAHO/WHO) - Ministers of health throughout the Americas have endorsed a series of actions to strengthen national regulatory systems in all Member States, in order to ensure that medicines and health technologies are safe, effective and of quality, and are tailored to the needs of national health systems. (paho.org)
The Policy to Strengthen National Regulatory Systems for Medicines and Other Health Technologies, adopted today by the 30th Pan American Sanitary Conference of the Pan American Health Organization (PAHO) sets out a series of recommendations to strengthen governance and capacities of regulatory systems, improving regional integration and promoting convergence. (paho.org)
Regulatory systems are critical for ensuring the availability of quality medicines and other health technologies, such as diagnostics and personal protective equipment, as well as for promoting equitable access to these products," said James Fitzgerald, Director of Health Systems and Services at PAHO. (paho.org)
Washington, D.C., April 26, 2021 (PAHO) The COVID-19 pandemic has demonstrated the urgent need for strengthening national regulatory authorities in Latin America and the Caribbean to ensure the safety and effectiveness of new medicines and medical products, a new report by the Pan American Health Organization (PAHO) asserts. (paho.org)
The report shows that national regulatory authorities vary dramatically in their capacity to evaluate medicines and medical products. (paho.org)

Medical device epidemiology and surveillance / edited by S. Lori Brown, Roselie A. Bright, and Dale R. Tavris. (who.int)

Although the CSL TIV vaccine was not recommended for use in young children in the US, during the 2010-2011 influenza season near real-time surveillance was conducted for febrile seizures in the 0-1 days following first dose TIV in a cohort of 206,174 vaccinated children ages 6 through 59 months in the Vaccine Safety Datalink Project. (nih.gov)
There are reports of seizures and other nervous system side effects in infants and children who were exposed to eucalyptus oil. (medlineplus.gov)

Similar provisions on Post-Market Surveillance are found in the European regulation on in vitro diagnostic medical devices (IVDR). (wikipedia.org)
They develop pharmaceutical products and services, can coordinate pharmaceutical assistance policies and act in the regulation and inspection of pharmaceutical establishments, products and services. (averwage.com)
The Regulation does not apply to products manufactured and used exclusively in healthcare facilities established in the European Union, " in-house products " (Article 5.5), provided they meet strict requirements (including ISO 15189). (oqotech.com)

The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. (pagefreezer.com)
With this delivery system, therapeutic blood concentrations are reached within 6-24 hours of a single dose. (tevapharm.com)

It is a passive surveillance system and is therefore subject to substantial underreporting. (psychiatrist.com)
METHODS: VAERS is a national passive surveillance system for adverse events (AEs) following immunization that uses the Medical Dictionary for Regulatory Activities to code reported AEs and the Code of Federal Regulations to classify reports by seriousness. (cdc.gov)

We analyzed data from 49 randomized, controlled clinical trials in the pediatric development programs for these products. (aap.org)
Safety of a product is assessed all along its lifecycle , from early development , clinical trials , marketing authorization to post-marketing. (voisinconsulting.com)

However, as ASHP has commented in the past regarding OTC status approval, actual-use studies should be required for all therapies that may be available without a prescription, just as these studies are required for products moving from prescription to nonprescription status. (ashp.org)
Additionally, pre-approval clinical studies and systematic data collection from postmarketing surveillance should play a critical role in assessing whether a product is appropriate for OTC status. (ashp.org)
ASHP recommends that a drug's continued nonprescription status be assessed based on data from postmarketing surveillance, epidemiological studies, and adverse event reporting. (ashp.org)
Please note: Kenya is party to the Nagoya Protocol on Access and Benefit-sharing ( KEN-3 ), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). (nih.gov)
Conformity assessment is based on clinical performance studies, quality management and technical documentation from the manufacturer, but only for one representative product per product category (Article 48.9). (oqotech.com)
Our Bioequivalence (BE) Recommendations for Specific Products database provides guidance on how to design BE studies for specific drug products to support ANDAs. (pagefreezer.com)
Thanks to a well-structured Quality Department, we have a highly qualified GCP system in place, granting the implementation of quality assurance in all our studies. (qualitecfarma.com)
Two recent studies have raised questions about postmarketing safety issues with newly approved drugs, particularly those granted approval on the basis of limited data. (medscape.com)

To gain a better understanding of the capacity of psychostimulant medications to induce adverse psychiatric reactions and determine the frequency of such reactions, we analyzed postmarketing surveillance data and clinical trial data for drugs, either approved or under development, for the treatment of attention-deficit/hyperactivity disorder. (aap.org)
The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly. (medicines.org.uk)
Postmarketing surveillance conducted in Japan by Biken and the governmental Relief Systems for Adverse Reactions have identified no cases of secondary transmission since Biken's vOka was licensed in 1985 (Y.G. and N.I., unpub. (cdc.gov)

Additionally, we can monitor for compliance with the study plan, protocol and IRB review, and control of investigational products, as well as report safety data, inform sites about performance and contractual issues, and serve as a point of contact between site, sponsor, CRO and IRBs. (syneoshealth.com)

As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients. (medicines.org.uk)
Public and private healthcare experts have been struggling for years to establish electronic health information systems that can track and transfer a broad range of data in patient medical records. (pharmexec.com)
FDA recently signed a $72 million contract with the Harvard Pilgrim Health Care system to implement a distributed data model that will enable FDA to query databases established by CIGNA, Kaiser Permanente, and the HMO Research Network, among others. (pharmexec.com)
FDA's recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. (complianceonline.com)
These include all systems that "touch" product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. (complianceonline.com)
The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data. (complianceonline.com)
System size, complexity, business criticality, GAMP 5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety. (complianceonline.com)
The Institute of Medicine has called for a nationwide mandatory reporting system to be established, and the data received should be analyzed to identify safety issues that require a broad-based response. (mhmedical.com)
CONCLUSIONS: Analysis of passive surveillance data from over 5.6 million doses of MenB-4C distributed in the United States did not reveal new safety concerns. (cdc.gov)
We can also train investigators and site staff on protocol requirements, best practices and technology tools, such as electronic data capture (EDC) and safety systems. (syneoshealth.com)
Estimating influenza disease burden from population-based surveillance data in the United States. (cdc.gov)

We aimed to assess the post-licensure safety profile of MenB-4C by examining reports received in the Vaccine Adverse Event Reporting System (VAERS). (cdc.gov)
Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS), 1990-2018. (cdc.gov)
Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016. (cdc.gov)

The manufacture of increasingly complex medical products requires stronger surveillance and control. (paho.org)

The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). (wikipedia.org)
The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. (wikipedia.org)
From pre-market product safety to post-market surveillance, we provide integrated vigilance services all along your product life cycle. (voisinconsulting.com)

Pharmaceuticals they work in public or private institutions, in pharmacies and drug distribution networks, in the pharmaceutical and related products industries, in the food and cosmetics industries, among others. (averwage.com)

Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse events management and post-marketing surveillance. (complianceonline.com)
Adverse events involving the vOka products from Merck (e.g., rash, varicella, herpes zoster, neurologic complications, and secondary transmission) have been reported at an overall rate of 3.4-5.3 events/10,000 doses given in the United States ( 2 , 6 ). (cdc.gov)

Medical device developers are anxious to plan how they might be able to develop the level of evidence that would meet your expectations" for future products, Binita Ashar, MD, a senior official in FDA's Center for Devices and Radiological Health, told the panel. (medscape.com)

In the table below, we list the types of products for each risk category and the conformity assessment procedure (Article 48). (oqotech.com)
Conformity assessment is carried out in accordance with Chapter I - Quality Management System, Chapter II - Assessment of Technical Documentation (excluding Section 5) and Chapter III - Administrative provisions of Annex IX of the IVDR. (oqotech.com)

serves as a guidance tool for any person responsible for handling traces in AHP products. (edana.org)
Group (Work Group) met at least monthly to review available surveillance will direct future guidance. (cdc.gov)
This webinar will also provide guidance on the importance of factoring risk into all FDA-regulated activities, and will help you assess the risk of any computer products purchased from third-party vendors. (complianceonline.com)

We do take a lifecycle approach to a drug product-from the first human exposure all the way through its continued marketing life-and we monitor the safety throughout. (medscape.com)

Independently, cases of psychosis or mania in children and adults for drugs used to treat attention-deficit/hyperactivity disorder from the Food and Drug Administration Adverse Event Reporting System safety database were analyzed. (aap.org)
The SAEDR scores had Spearman correlations of 0.595, 0.633, and −0.748 for death, serious outcome, and no outcome, respectively, with ADR case outcomes in the Food and Drug Administration Adverse Event Reporting System. (jmir.org)
001). We created quantitative drug-risk profile (DRIP) scores for 968 drugs that had a Spearman correlation of 0.377 with drugs ranked by the Food and Drug Administration Adverse Event Reporting System cases resulting in death, where the given drug was the primary suspect. (jmir.org)
3 The regulatory agency that is responsible for postmarketing safety surveillance (PMSS) in America is the Food and Drug Administration (FDA). (mhmedical.com)

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)
To support the development and equitable distribution of COVID-19 products, WHO and partners established the Access to COVID-19 Tools (ACT) Accelerator initiative in April 2020. (who.int)

Increased connectivity among healthcare entities promises to affect more efficient drug testing and development, along with more timely medical product monitoring and oversight. (pharmexec.com)
Healthcare databases generally differ by underlying healthcare systems, type of information collected, drug/vaccine and medical event coding systems and language. (eur.nl)
CDC, our planners, and presenters wish to disclose they have no financial relationship with any ineligible companies whose primary business is producing, marketing, selling, reselling, or distributing healthcare products used by or on patients. (cdc.gov)

Throughout the past decade, the region has made vast improvements in the development of oversight capacity and systems, including in the designation of eight National Regulatory Authorities (NRA's) of regional reference with the necessary installed capacities to effectively oversee and sanction the approval of pharmaceutical products. (paho.org)
Financial and human resources for national regulatory authorities have remained relatively static over the last five years in Latin America while the pharmaceutical market has increased both in value, volume and medical product complexity. (paho.org)
Yet the pursuit of accelerating access, while safeguarding the safety, effectiveness and quality of the products, created tensions and pressures within national regulatory authorities," Dr. Barbosa said. (paho.org)

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. (complianceonline.com)

To receive approval for an Abbreviated New Drug Application (ANDA), an applicant generally must demonstrate, among other things, that its product has the same active ingredient, dosage form, strength, route of administration and conditions of use as the listed drug, and that the proposed drug product is bioequivalent to the reference listed drug (RLD). (pagefreezer.com)

Access is a global concern, given the high prices of new pharmaceuticals and rapidly changing markets for health products that place increasing pressure on all health systems' ability to provide full and affordable access to quality health care. (who.int)
they also need to be aligned with legal and regulatory frameworks and cover the entire product life cycle, from research and development to quality assurance, supply chain management and use. (who.int)
During manufacture, strict quality control systems are in use to ensure product quality and hygiene. (edana.org)
EDANA members carry out post-marketing surveillance of their products in which they actively respond to consumer comments to ensure continuously the quality and safety of their products. (edana.org)
They also carry out quality control actions for pharmaceutical products and services, managing the storage, distribution and transport of these products. (averwage.com)
All of them must ensure the traceability of the supply chain and also implement a quality management system and a risk management system. (oqotech.com)
Our global safety and vigilance team collaborates with clinical operations, regulatory, and others, to manage your safety and vigilance needs at any stage of product development to ensure quality and compliance. (voisinconsulting.com)
We uphold Quality Management System (QMS) and Quality Assurance (QA) procedures as the prime pillars of our way of work. (qualitecfarma.com)

The basic information you need to know about the product safety and regulatory requirements for placing absorbent hygiene products (AHP) on the market in the European Union. (edana.org)
This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment. (complianceonline.com)
Any person subject to the reporting requirements under paragraph (c) of this section shall also develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse experiences to FDA. (cdc.gov)
When a vendor is involved, whether in terms of provisioning hardware and/or software, implementing the system or maintaining it, this must be done in compliance with FDA requirements. (complianceonline.com)
In compliance with continuing education requirements, all planners and presenters must disclose all financial relationships in any amount with ineligible companies over the previous 24 months, as well as any use of unlabeled product or products under investigational use. (cdc.gov)

Manufacturer(s) have sought approval of the vaccine(s) and provided evidence as to its safety and efficacy only when it is used in accordance with the product monographs. (canada.ca)
Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. (complianceonline.com)

Health Canada is the regulatory body which approves drugs, and it has a division called "Marketed Health Products Directorate" (MHPD) which coordinates Canadian postmarketing surveillance. (wikipedia.org)
The primary purpose for maintaining the FDA/Center for Veterinary Medicine Adverse Drug Experiences (ADE) database is to provide an early warning or signaling system to the Center for adverse effects not detected during pre-market testing of FDA-approved animal drugs and for monitoring the performance of drugs not approved for use in animals. (pagefreezer.com)
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs. (pagefreezer.com)

Despite this progress, however, significant challenges and existing asymmetries persist: "in Latin America and the Caribbean, the allocation of financial and human resources for NRAs has remained relatively static over the last five years, while the pharmaceutical market has continued to increase in value, volume and product complexity," said Fitzgerald. (paho.org)

Annual estimates of the burden of seasonal influenza in the United States: A tool for strengthening influenza surveillance and preparedness. (cdc.gov)
Multistate surveillance for laboratory-confirmed, influenza-associated hospitalizations in children: 2003-2004. (cdc.gov)
Population-based surveillance for hospitalizations associated with respiratory syncytial virus, influenza virus, and parainfluenza viruses among young children. (cdc.gov)

Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases. (wikipedia.org)

It can cause serious problems with the nervous system. (medlineplus.gov)

The creation of the Caribbean regulatory system and the Central American joint working system reflect an improvement of regulatory capacity. (paho.org)

Robust regulatory capacities result from expansive legal and organizational frameworks, which give NRArs technical independence and strong mandates to supervise and sanction the pharmaceutical product approvals within their jurisdictions. (paho.org)
Unexpected,'' as used in this definition, refers to an adverse experience that has not been previously observed (i.e., included in the labeling) rather than from the perspective of such experience not being anticipated from the pharmacological properties of the pharmaceutical product. (cdc.gov)

The report raises concerns about the "limited or complete lack of legal and organizational frameworks for regulatory systems in a number of countries. (paho.org)

Millions of products are used safely each day and absorbent hygiene products manufacturers ensure that all products comply with local legislation and are safe for their intended and foreseeable uses. (edana.org)
The resolution established regulatory systems as a public health priority and underscored the need to ensure that medical products comply with international standards and are affordable and accessible. (paho.org)

Diseases2

Chemicals and Drugs2

Analytical, Diagnostic and Therapeutic Techniques and Equipment8

Anthropology, Education, Sociology and Social Phenomena2

Technology, Industry, Agriculture1

Information Science1

Health Care8

Geographicals2

Epidemiological surveillance1

Vaccine safety surveillance3

Conduct6

ADRs3

Pharmacovigilance6

Morbidity and morta1

FAERS3

Vaccines7

Office of Surveillance and Epidemiology1

Risk assessment3

MedWatch3

Medicines5

Epidemiology1

Seizures2

Regulation3

Therapeutic2

Passive surveillance system2

Clinical trials2

Studies8

Reactions3

Investigational products1

Data11

VAERS3

Requires stronger surveillance1

Post-Market Surveillance3

Cosmetics1

Adverse events2

FDA's Center1

Conformity assessment2

Guidance3

Lifecycle1

Food4

Equitable2

Healthcare3

National Regulatory Authorities3

Development Life1

Dosage1

Quality8

Requirements5

Accordance2

Drugs3

Complexity1

Influenza3

Approaches1

Nervous system1

Regulatory system1

Pharmaceutical product2

Frameworks1

Comply2