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MAY 2020
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in May 2020.
Finalized Draft Guidance Documents:
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers Guidance for Industry (Published 27May2020)
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Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff (Published 21May2020)
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma Guidance for Industry (Published 19May2020)
Guidance for Industry Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic (Published 11May2020)
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry (Published 11May2020)
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products Guidance for Industry and Investigators (Published 11May2020)
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Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff (Published 11May2020)
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components (Published 05May2020)
Investigational COVID-19 Convalescent Plasma Guidance for Industry (Published 01May2020)
New Draft Guidance Documents:
Orange Book Questions and Answers Guidance for Industry Draft Guidance (Published 27May2020)
Q3C(R8) RECOMMENDATIONS FOR THE PERMITTED DAILY EXPOSURES FOR THREE SOLVENTS—2-METHYLTETRAHYDROFURAN, CYCLOPENTYL METHYL ETHER, AND TERT-BUTYL ALCOHOL—ACCORDING TO THE MAINTENANCE PROCEDURES FOR THE GUIDANCE Q3C IMPURITIES: RESIDUAL SOLVENTS (Published 26May2020)
FDA seeks input on rare disease clinical trials network (Published 29May2020)
FDA looks to overhaul Orange Book, seeks input on patent listings (Published 29May2020)
FDA releases EUA template for COVID-19 home sample collection kits (Published 29May2020)
EMA explains GMP and GDP flexibilities amid COVID-19 (Published 28May2020)
Health Canada releases guidance to streamline COVID-19 clinical trials (Published 28May2020)
COVID-19 therapeutics tracker (Published 28May2020)
UK grants early access to remdesivir for COVID-19 (Published 26May2020)
EMA strengthens ENCePP mandate to address COVID-19 pandemic (Published 26May2020)
Multinational efforts build framework for real-world and observational COVID-19 data (Published 21May2020)
FDA names companies removed from antibody test list (Published 21May2020)
EMA extends virtual-only meeting policy through August (Published 20May2020)
Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response (Published 19May2020)
FDA updates COVID-19 clinical trials guidance to address serious adverse events (Published 18May2020)
FDA addresses interstate distribution of compounded drugs in new MOU (Published 18May2020)
EMA waives certain GMP inspection fees during COVID-19 (Published 15May2020)
Electronic platforms for submission of clinical trial information (Published 14May2020)
Purple Book: FDA adds transition biologics as move to single database progresses (Published 12May2020)
Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19 (Published 11May2020)
Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19 (Published 11May2020)
EMA preparing big data Q&A guidance (Published 11May2020)
GAO finds HHS not using new authority for hiring top scientists at FDA, NIH (Published 08May2020)
COVID-19: FDA fights wave of fraudulent products (Published 07May2020)
Japan approves Gilead Sciences' remdesivir as COVID-19 drug (Published 07May2020)
CDER releases policy for handling newly identified safety signals (Published 05May2020)
WHO: FREQUENTLY ASKED QUESTIONS BY THE MANUFACTURING, TRIAL AND TESTING ORGANIZATIONS IN CONNECTION WITH SOME OF THEIR CONSTRAINTS FACED DURING THE COVID-19 OUTBREAK (Published 05May2020)
EMA details rapid procedures for COVID-19 products (Published 04May2020)
FDA authorizes Gilead’s remdesivir for emergency use (Published 01May2020)
- Explore the Veristat COVID-19 Resource page
- Download our COVID-19 Guide on Strategie For Success During the COVID-19 Era
- Read our infographic to Understand FDA Expedited Pathways for Accelerating Time-to-Market for Products Treating Serious Conditions or Unmet Medical Needs
- Download the Infographic explaining the Types of FDA Meetings with CDER and CBER
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