Meet regulatory guidance. Medical search. Frequent questions

On Wednesday, June 14, 2023, the IRS released its long-awaited initial guidance and proposed regulations regarding the newly created direct payment election methodology. (bricker.com)
The National Association of Insurance Commissioners ("NAIC") recently concluded its summer meeting, which took place from August 12 to 16, 2023. (jdsupra.com)
The National Association of Insurance Commissioners (NAIC) held its 2023 Summer National Meeting from August 12 to 16 in Seattle, Washington. (jdsupra.com)
The Mitchell Williams Insurance Regulatory team of lawyers recently attended the National Association of Insurance Commissioners (NAIC) 2023 Summer National Meeting which was held in Seattle, Washington. (jdsupra.com)
On August 13, 2023, insurance regulators and the insurance industry met in Seattle, Washington at the NAIC Summer Meeting and continued to address the challenges of monitoring and regulating the insurance industry's use of. (jdsupra.com)
EUR 1m in artificial intelligence in Q4 2022/2023, recognized in the income statement, EBIT came in at EUR 45, which is 9.3 % above the prior-year figure (PY EUR 41, guidance EUR 45-48m). (menafn.com)

An informal technical meeting of the risk-based post-market surveillance technical working group of experts developing the survey tool chaired by the Secretariat was convened on 21 October 2019. (who.int)
The Fall 2019 National Organic Standards Board (NOSB) Meeting will be October 23-25 at the DoubleTree by Hilton Hotel & Suites Pittsburgh City Center in Pittsburgh, PA. (ota.com)
The Organic Trade Association's complete report on the Fall 2019 National Organic Standards Board (NOSB) meeting is now available! (ota.com)
The Financial Action Task Force ("FATF") held the third and final Plenary meeting under the US Presidency in Florida from June 19-21, 2019, during which delegates discussed several major strategic initiatives of the FATF (e.g., launching a strategic review to analyze progress toward effective implementation of AML/CFT measures), as well as recent mutual evaluation reports (including reports from Hong Kong) and follow-up reviews. (mayerbrown.com)
The updated virtual asset guidance follows revisions to the FATF Recommendations in October 2018 and June 2019 to address the growing use of virtual assets for money laundering and terrorist financing. (mayerbrown.com)
The next FATF Plenary meeting will take place in Paris from October 13-18, 2019. (mayerbrown.com)
In May of 2019, the US FDA issued industry guidance, Considerations in Demonstrating Interchangeability with a Reference Product, to companies wishing to develop biosimilars in the US market. (westpharma.com)

The guidance clarifies that staffing agencies may be responsible for ensuring compliance with U.S. Department of Transportation (DOT) drug and alcohol program requirements including drug and alcohol testing, driver education and record retention. (cvsa.org)

Your restaurant or bar must meet both state and local regulations for serving alcohol. (score.org)
The most illustrative part of the IRS's initial guidance and proposed regulations discussed the creation of the pre-filing registration process and the associated requirements. (bricker.com)
The latest reforms in Chinese regulations have increased regulatory efficiency and transparency, resulting in better alignment with international approaches. (sigmaaldrich.com)
Prior blogs in this series enumerated on the regulatory bodies and regulations, as well as how organizations can live in a multi-controller world. (cisco.com)
Specific within some regulations, you will find advanced guidance on evolving technologies, especially with the 2021 update to the FFIEC operations book. (cisco.com)
These regulations will continue to evolve, and being able to harness the power of the automation systems can save organizations operational costs in meeting them. (cisco.com)
This guidance document supports amendments to section 1 and the introduction of sections 62.21 to 62.26 of the Medical Devices Regulations (Regulations), which go into effect on March 2, 2022. (canada.ca)
Services must meet the standards in the regulations and the requirements of the licensing criteria to gain and maintain a licence to operate. (ero.govt.nz)
The executive order further instructs the head of each agency administering statutes or regulations that prohibit sex discrimination-which would include ED's administration of Title IX-to consider in the next 100 days whether to issue new guidance documents "as necessary to fully implement statutes that prohibit sex discrimination and the policy set forth in section of this order. (bricker.com)
Phillips Lytle Environmental Law attorneys offer guidance on the state and federal laws and regulations related to the registration, testing and closure of tanks and storage facilities. (phillipslytle.com)
The OPC held a consultation on online tracking and related activities in 2010 (CIPPIC's submission to this) and the CRTC recently completed a proceeding on the parameters for regulations arising from CASL which touched on some portion of these broader Information Bulletins [Telecom Notice of Consultation CRTC 2011-400 which resulted in Telecom Regulatory Policy CRTC 2012-183 ]. (cippic.ca)

As FDA clarifies in the draft guidance, an RRA is an "examination" rather than an inspection (in most cases), because the latter involves FDA physically entering an establishment for purposes of determining compliance with FDA requirements. (jw.com)
The Life Science industry operates in one of the world's most regulated environments with an increase in regulatory requirements and complexity. (sigmaaldrich.com)
On Dec. 23, 2016, FMCSA issued guidance for driver staffing agencies who employ CMV operators and who are subject to commercial driver's license (CDL) requirements. (cvsa.org)
Regulatory requirements around software validation can make it difficult for manufacturers to access current technology and maintain up-to-date systems. (epicor.com)
In return you will receive input from the regulatory agencies related to regulatory project review and potential mitigation requirements. (tn.gov)
structured to clearly distinguish between mandatory requirements that must be met by an applicant and guidance which may assist an applicant meet the essential requirements. (arpansa.gov.au)
provide guidance based on national and international best practice for meeting the requirements and attaining high levels of safety and security. (arpansa.gov.au)
Parts 4 and 5, ' Technical Aspects of Site Selection ', provide guidance from international best practice for consideration by the applicant in meeting the relevant requirements. (arpansa.gov.au)
The platform also changes and displays appropriate consent banner's based on the user's location to help companies meet consumer consent requirements. (golden.com)
TrustArc's Privacy Assessment offers users automated end-to-end assessments to find gaps, record risks, manage tasks, maintain audit trails, and produce compliance reports to meet regulatory requirements. (golden.com)
This blog will explore how financial institutions (FIs) can use different Cisco technologies to help meet regulatory requirements, be they FFIEC, OCC, PCI, or others. (cisco.com)
It provides a range of benefits for FIs, including helping them meet regulatory requirements through its extensive automation capabilities. (cisco.com)
Network Segmentation: One of the key regulatory requirements for FIs is to ensure network segmentation to isolate sensitive data and systems. (cisco.com)
Compliance Reporting: FIs are required to maintain compliance reports to demonstrate their adherence to regulatory requirements. (cisco.com)
Enhanced Security: Through advanced features like integration with Talos and endpoint classification, as well as automated workflows for the provisioning of advanced security resources like encrypted traffic analytics, DNA Center is helping FIs implement the policies to meet their regulatory requirements. (cisco.com)
Editorial -Produces content supporting decision tools, performance and help meet regulatory requirements, which help the Professionals. (ananova.com)
The Office of the State Treasurer will report its findings regarding its review of sufficiency of current SR 520 toll rates meeting legal revenue requirements. (wa.gov)
Ofgem released draft guidance in December 2017 seeking to clarify existing guidance on the requirements that generators must satisfy under the RO and FIT Schemes if storage is co-located with generation accredited under these schemes. (twobirds.com)
The draft clarifies that a generator may claim Renewables Obligation Certificates (ROCs) for electricity supplies to a third party storage facility by private wire if the relevant requirements are met. (twobirds.com)
FIT generation payments are reliant on meeting Ofgem's requirements including that the meter reading reflects only eligible electricity under the FIT scheme. (twobirds.com)
Some of the tasks that we've been focused on include laboratory biosafety, the regulatory requirements under the Clinical Laboratory Improvement Amendments Act, known as CLIA, and additional laboratory quality issues, and the challenges associated with implementing laboratory- developed tests. (cdc.gov)
All but one of the financial regulators have guidelines that restate RFA requirements for certification and for preparing regulatory flexibility analyses and provide some information on how to approach these analyses. (gao.gov)
GAO also determined the extent to which regulators' analyses reflected RFA requirements, guidance issued by the Office of Advocacy, and OMB guidance on regulatory analysis. (gao.gov)
GAO is making a total of 10 recommendations among the six financial regulators reviewed, including that regulators develop and implement specific policies and procedures for consistently complying with RFA requirements and related guidance for conducting RFA analyses. (gao.gov)
Guidance for managing asbestos identification, notifications and abatement requirements, OSHA and air emission requirements and asbestos inventory and management plans are all part of the services that Phillips Lytle Environmental lawyers provide to our clients. (phillipslytle.com)
The Phillips Lytle Environmental Law Team assists with the assessment of state and federal regulatory requirements and compliance, development and presentation of voluntary disclosure, assessment of enforcement policies and penalty mitigation. (phillipslytle.com)
The guidance manual outlines Ontario's hazardous waste management rules and the requirements for generators, carriers and receivers of subject waste as set out in Ontario Regulation 347 and Ontario Regulation 323/22. (ontario.ca)
To overcome procurement barriers and ensure access to novel COVID-19 therapeutics in PICs, WHO`s pandemic support to Member States focused on strengthening regulatory requirements, safety monitoring and supply chain activities. (who.int)
What are the regulatory requirements? (lu.se)
The templates are designed to meet the requirements of Science Europe. (lu.se)
Training concepts were specifically matched to the constructs of the modified HPM along with meeting OSHA training requirements. (cdc.gov)

The draft guidance indicates FDA's intention to continue to use remote tools to support oversight activities, including a hybrid approach for inspections that combines both onsite and remote modalities, beyond the COVID-19 pandemic. (jw.com)
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. (fda.gov)
LUPKIN: They'll be discussing FDA's existing guidance to companies, which includes some of that information. (keranews.org)

As a result of current events related to the COVID-19 pandemic and the associated impact on firms' available resources to implement technology changes, FINRA is delaying the March 30, 2020, effective date for firms to begin submitting the last four digits of a customer's Social Security or tax identification number and the update for certain validation identifiers and validation criteria to meet Regulation T calls. (finra.org)

On July 22, the U.S. Food and Drug Administration released draft guidance entitled Conducting Remote Regulatory Assessments: Questions and Answers (FDA-2022-D-0810). (jw.com)
In February 2022, CAP and BCAP consulted on new rules and guidance to regulate alcohol alternative products and provide clarity to advertisers. (asa.org.uk)

The relevant Australian regulatory and safety standards framework is summarised in this introductory chapter (Part 1). (arpansa.gov.au)
Biosimilar developers need to demonstrate similar efficacy as the innovator's reference product, while also understanding the appropriate regulatory framework and necessary test regime for the biosimilar. (westpharma.com)
Ontario has a comprehensive legislative and regulatory framework in place to ensure that hazardous waste and liquid industrial waste ( LIW ) are managed in an environmentally safe manner. (ontario.ca)

On Dec. 29, 2016, FMCSA announced a meeting of the Advisory Committee on Automation in Transportation (ACAT) on Jan. 16, 2017. (cvsa.org)
On Dec. 28, 2016, FMCSA announced a Unified Carrier Registration (UCR) Board of Directors meeting on Feb. 7, 2017. (cvsa.org)

However, as the draft guidance states, although declining a voluntary RRA does not result in any enforcement action by FDA, it may delay FDA in making a timely decision on a product approval, clearance, or authorization. (jw.com)
The presence of nitrosamines in pharmaceutical products has emerged as a public health concern, leading health authorities to provide guidance for Marketing Authorization holders and manufacturers alike to perform risk assessments and implement mitigation strategies in case of possible contamination. (sigmaaldrich.com)
In addition, WHO supported PICs by providing trainings in clinical management of COVID-19, developing critical supply needs estimates, and facilitating regulatory approval of clinical therapeutics, including emergency use authorization. (who.int)

The draft guidance also clarifies the process following an RRA. (jw.com)

We serve as the unifying voice of the U.S. organic industry on Capitol Hill, and we advance our mission to promote and protect organic agriculture and trade through legislative and regulatory advocacy. (ota.com)

Article - Delivers integrated information, solutions and expert guidance from professionals about technology industries. (ananova.com)

What are remote regulatory assessments? (jw.com)
Remote regulatory assessments (RRAs) are a type of remote oversight tool that FDA may use to support regulatory decisions and oversight activities. (jw.com)
Why does FDA use remote regulatory assessments? (jw.com)
What should companies know about remote regulatory assessments? (jw.com)
This was because results of interim studies indicated that the assessments were unlikely to meet their primary endpoints in the intent-to-treat patient population. (yahoo.com)

RRAs include, for example, "remote interactive evaluations," on which FDA has previously released guidance for their use during the pandemic. (jw.com)
Best practices , guidance documents, infographics, signage and more for the food industry on the COVID-19 pandemic. (fmi.org)

OBJECTIVE: The purpose of this study was to examine guidance for the protection of health information when using ICT from all 10 of Canada's provincial regulatory colleges for physicians and to discuss the potential policy and service delivery implications. (bvsalud.org)

The draft guidance is open for comments until September 23. (jw.com)
The draft guidance catalogues examples where FDA may initiate or request to conduct an RRA. (jw.com)
The draft guidance provides context on RRAs to assist establishments that may be unfamiliar with the process. (jw.com)
Indeed, the draft guidance clearly documents the value of RRAs, from the perspective of FDA, and begins to clarify outstanding questions from industry on the future use of RRAs. (jw.com)
Find our article here outlining the implications of the draft guidance on RO and FIT installations. (twobirds.com)

Aligning different perspectives and considering engineering, regulatory, and clinical needs can be cumbersome. (medicaldesignbriefs.com)
LUPKIN: She hopes the meeting will delve into making sure the clinical trials are diverse, for example. (keranews.org)

Unfortunately, there is little clear guidance on what constitutes permissible factual information as opposed to prohibited advocacy. (bricker.com)

Because this meeting will be the last for four public governors- Leslie Seidman , Shelly Lazarus , Brigitte Madrian and Luis Viceira -the Nominating and Governance Committee of the Board is scheduled to meet to continue discussions around the important task of appointing their successors. (finra.org)

Activity A: Develop and promote training material and guidance documents to strengthen the capacity of national/regional regulatory authorities for the prevention and detection of, and response to, substandard and falsified medical products. (who.int)
One objective is to strengthen policies and regulatory frameworks to promote, protect and support the consumption of safe and healthy foods. (who.int)

The United States Department of Transportation recently issued a new report on automated vehicle technologies, including voluntary standards and guidance. (wa.gov)

After completion of an RRA, FDA may conduct a meeting with the management team to present a written list of "observations" (i.e., conditions or practices observed that may indicate potential compliance violations), if any. (jw.com)
Consistent implementation and monitoring of practices is required to meet regulatory standards. (ero.govt.nz)

Feedback on the content and guidance provided by the document is welcome in order to assist with the updating, improvement, and further development of subsequent editions. (cdc.gov)
METHOD: A search of the regulatory college websites was conducted, followed by a document analysis (content and thematic). (bvsalud.org)

This document is the regulatory statement we've made following the consultation period and as we implement the new rules. (asa.org.uk)
Applicants are encouraged to use the PRM guidance document to create a compensatory mitigation plan. (tn.gov)
This suggests that prior guidance on transgender students and its accompanying Q&A document , issued in May 2016 under the Obama administration but withdrawn under the Trump administration, may give some indication as to what ED may do next in this area while we wait for new guidance to be released. (bricker.com)
SAICM) regarding the function of the secretariat "to facilitate the development and dissemination of guidance materials to support implementation of the Strategic Approach by stakeholders", this document has been prepared to assist with the development of SAICM implementation plans at the national, regional, and organizational levels. (cdc.gov)
The Conference took note of the guidance document and called for its further development by the secretariat and UNITAR in consultation with other stakeholders. (cdc.gov)

Your medical device developer can help you assess regulatory considerations so you're not hit with a costly violation down the road (or worse - hurt a patient). (genesisplasticswelding.com)

Represented a Fortune 500 life sciences company on an array of environmental regulatory matters, including process wastewater and storm water discharge permitting. (phillipslytle.com)

We assist with development and implementation of environmental regulatory law initiatives from environmental programs to environmental management systems. (phillipslytle.com)

FDA met or exceeded all GDUFA review goals to date, including goals for original Abbreviated New Drug Applications (ANDAs), ANDA amendments, Prior Approval Supplements (PAS), and controlled correspondence. (fda.gov)

The guidance also defines "casual, intermittent and occasional" drivers and explains that employers who use these drivers must verify the driver's participation in a DOT drug and alcohol testing program every six months. (cvsa.org)
Factors such as intermittent and highly variable noise levels, lax regulatory enforcement, lack of awareness and knowledge of harmful noise levels, attitudes and beliefs towards using hearing protection devices (HPDs) and the improper use of HPDs contribute to construction workers' NIHL. (cdc.gov)

New design features or historical testing results may not meet the current expectations for validation testing. (medicaldesignbriefs.com)
This new guidance provides direction to biosimilar manufacturers on the FDA expectations for demonstrating interchangeability of a proposed therapeutic protein product with the reference biologic product. (westpharma.com)

The FDIC has announced a series of steps intended to provide regulatory relief to financial institutions and facilitate recovery in areas of Michigan affected by severe storms and flooding. (fdic.gov)
The guidance documents provide principles to consider when validating reprocessing instructions in order to meet a worst-case study design. (medicaldesignbriefs.com)
AdviceOnline entries provide guidance on interpreting the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing. (asa.org.uk)
Assurance Review reports provide information about whether a service meets and maintains regulatory standards. (ero.govt.nz)
For most rules GAO reviewed, regulators (five of six) were unable to provide documentation supporting their regulatory flexibility analyses, as OMB recommends, including analyses supporting certification decisions. (gao.gov)
The Environmental Law and Land Use, Permitting and Zoning Teams provide guidance in filing applications for, and modifications to, state and federal discharge permits for point source and non-point source discharges and toxic water pollutants, storm water pollution prevention plans and discharge compliance. (phillipslytle.com)

12 of these documents (from 8 of the 10 colleges) met the study criteria. (bvsalud.org)

Other regulatory bodies (ISO, ANSI, ASTM) may have additional performance standards you must adhere to. (genesisplasticswelding.com)

Institutions can expect the need to implement policies differently or make policy revisions in the coming year as new guidance is released, including but not limited to, policies covering Title IX, facility use and athletics. (bricker.com)

The energy storage market has demonstrated significant growth and promise in recent years with infrastructural and regulatory developments showing both private and public commitment to increasing the role of storage on the UK electricity grid. (twobirds.com)

Click here to setup a resource meeting with Graham, the BA's Engagement Coordinator. (brewersassociation.org)

To comply with the Regulatory Flexibility Act (RFA), agencies generally must assess the rule's potential impact on small entities and consider alternatives that may minimize any significant economic impact of the rule (regulatory flexibility analyses). (gao.gov)

In lieu of our standard FINRA Board meeting-which typically includes a full schedule of committee meetings and a review of rule proposals-this meeting will instead revolve around a series of strategic planning discussions. (finra.org)
Today's meeting of the committee that looks at vaccines is going to be a little different. (keranews.org)
The same committee will meet again to evaluate individual vaccines. (keranews.org)
The Regulatory Committee under the Tobacco Products Directive set up a working group to support the Commission in this work. (who.int)

Use this page to navigate over a wide range of specialities and access to dedicated regulatory expertise. (sigmaaldrich.com)

We'll get them to our main presentation of the updated storage and shipping guidance for submission to CDC infectious disease laboratories. (cdc.gov)

The worst-case approach is a function of U.S. Food & Drug Administration (FDA) and AAMI literature guidance, which exposes areas where reprocessing directions may fall short. (medicaldesignbriefs.com)
Additionally, the FATF published an updated Guidance for a Risk-Based Approach to Virtual Assets and Virtual Asset Service Providers , which describes how countries and virtual asset service providers can satisfy their AML/CFT obligations with respect to these assets. (mayerbrown.com)
This briefing will report on the federal approach to autonomous vehicle development and contrast its guidance with the approach taken internationally. (wa.gov)

In many of the initial and final regulatory flexibility analyses that GAO reviewed, financial regulators' evaluation of key components required by RFA-potential economic effects and alternative regulatory approaches-was limited. (gao.gov)
By not developing and implementing comprehensive policies and procedures for RFA analyses, regulators' ability to consistently and effectively meet RFA objectives may be limited. (gao.gov)

In this atmosphere of heightened concerns, two sets of regulatory guidelines, both issued last week, may shed light on the obligations of those in the app market to protect user privacy and the right to be left alone. (cippic.ca)

Applicants seeking a Tennessee Department of Environment and Conservation (TDEC) Aquatic Resource Alteration Permit (ARAP)/Section 401 Water Quality Certification and a U.S. Army Corps of Engineers (USACE) Clean Water Act Section 404 Permit can request a regulatory coordination meeting if the proposal is complex and/or a large-scale project with the potential to significantly impact water resources, especially those in which permittee-responsible mitigation (PRM) is proposed. (tn.gov)
If you have a project proposal that meets a category listed below, you may request a regulatory coordination meeting with TDEC and USACE personnel on one of the dates provided below. (tn.gov)
Before requesting a pre-application meeting, consider whether your project can benefit from regulatory coordination. (tn.gov)
To request a pre-application meeting please fill out the REQUEST FOR REGULATORY COORDINATION (form CN-1610) and submit by e-mail to [email protected] AND [email protected] . (tn.gov)
Please submit your requests for regulatory coordination meetings at least two weeks in advance of the meeting date for which you are applying. (tn.gov)

GAO's review covered certifications in 66 final rules and regulatory flexibility analyses in 39 proposed and final rules. (gao.gov)

They will need to consider whether the techniques described can yield passing validation results that meet the current standards, guidance, or latest scientific trends. (medicaldesignbriefs.com)
Based on this new order, it is expected that ED will need to revise its current guidance. (bricker.com)
Dr. Elmer Akin, the ORRHES liaison to the U.S. Environmental Protection Agency (EPA), will no longer serve in this capacity after the current meeting due to his retirement from the agency. (cdc.gov)

This Regulatory Guide replaces the draft Regulatory Guide RG-4 Criteria for the Siting of Controlled Facilities (ARPANSA 1999). (arpansa.gov.au)
Across these regulatory audit criteria a number of fundamental constructs remain consistent. (cisco.com)
If the organization relies on the services or components of another organization, policies and procedures describe the steps followed (e.g., criteria, evaluation, or monitoring) to evaluate whether the service or component meets the relevant accreditation standards. (aahrpp.org)

The organization maintains adequate resources for support of the operations of the HRPP, including but not limited to resources such as space and personnel, in order to meet the accreditation standards. (aahrpp.org)

Represented a Fortune 500 company in environmental regulatory matters, including wastewater discharges, hazardous substance and petroleum releases/spills, and RCRA matters. (phillipslytle.com)

Guidance is presented on methods to evaluate mixed exposures from a scientific and regulatory perspective. (cdc.gov)

Medical devices are subjected to strict regulatory standards, like those set by the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency). (epicor.com)
Since the onsite visit, the service has provided ERO with evidence that shows it has addressed non-compliances and is now taking reasonable steps to meet regulatory standards. (ero.govt.nz)
The vaccine was approved after it was found to meet the MHRA's standards of safety, quality and effectiveness. (www.gov.uk)
The organization has allocated the financial and personnel resources and space necessary to carry out the operations of the HRPP in order to meet the accreditation standards. (aahrpp.org)

The initial guidance provides clarity regarding who must own the energy property to claim the credit, the process and instructions for filing the tax returns required to receive the elective payment, how to successfully elect to receive the elective payment, and how to make sure one receives the maximum amount of credit that its energy project is eligible for. (bricker.com)

This Regulatory Guide has been prepared to advise potential Commonwealth applicants, the public, and other stakeholders of the issues that will have to be addressed by an applicant when applying for a licence under the ARPANS Act to prepare a site for a controlled facility. (arpansa.gov.au)

Mr. Jerry Pereira, the ORR Project Manager, usually presents the report but he was unable to attend the meeting. (cdc.gov)
Ms. Dalton provided a status report of action items raised during the previous meeting. (cdc.gov)
ATSDR mailed CDC's report of the 1998 health study of the Scarboro community to ORRHES following the April 2003 meeting. (cdc.gov)

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued detailed guidance on the new International Recognition Procedure (IRP) for medicines manufacturers, including how to apply for a medicine licence. (www.gov.uk)
WHO), Stop TB Department) on the basis of consensus at an international Expert Group meeting convened by WHO in Geneva, Switzerland on 29-30 January 2013. (bvsalud.org)

It was agreed that the development of the tool should proceed under the chairmanship of the Secretariat and a parallel technical working group chaired by Brazil should be established to develop the guidance. (who.int)
For the new action proposed on risk-based post-market surveillance and led by Brazil, a working group of Member States would be formed, with next steps to include the development of terms of reference for the working group on guidance. (who.int)
Any Member State interested in joining this working group on the development of guidance on risk-based post-market surveillance was encouraged to contact the Secretariat as soon as possible. (who.int)
The NAIC's Privacy Protections (H) Working Group met over the weekend as part of the NAIC's Summer National Meeting. (jdsupra.com)
The working group met four times. (who.int)

Regulatory guidance from agencies such as Health Canada and the U.S. Food and Drug Administration (FDA) states that the environment is the predominant source for Listeria contamination of food. (neogen.com)

LUPKIN: Well, the FDA regularly turns to committees of outside advisers for guidance. (keranews.org)

Government Affairs work - federal and state - on the latest food industry policy, regulatory and legislative issues. (fmi.org)
The use of bedaquiline in the treatment of multidrug-resistant tuberculosis: interim policy guidance. (bvsalud.org)

Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center . (medscape.com)

For any regulatory submission of a medicinal product, data and risk assessment of potential leachables are required when single-use systems (SUS) are used in the manufacturing process. (sigmaaldrich.com)
Met or Exceeded All Submission Review Goals to Date. (fda.gov)

Anatomy2

Chemicals and Drugs2

20236

20197

Ensuring compliance1

Regulations11

Requirements31

FDA's3

20201

20222

Framework3

20172

Authorization3

Clarifies1

Legislative and regulatory1

Expert guidance1

Assessments5

Pandemic2

Canada's1

Draft guidance5

Clinical2

Advocacy1

Governance1

Strengthen2

Voluntary1

Practices2

Content2

Document5

Considerations1

Life Sciences1

Implementation1

Amendments1

Intermittent2

Expectations2

Provide6

Documents1

Bodies1

Revisions1

Developments1

Coordinator1

Alternatives1

Committee4

Expertise1

Laboratories1

Approach3

Regulators2

Obligations1

Coordination5

Rules1

Current3

Criteria3

Support1

Hazardous1

Evaluate1

Standards4

Clarity1

Applicants1

Report3

International2

Working group5

Food and Drug Admin1

Regularly1

Policy2

NEWS1

Submission2