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April 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 April 2020.
Finalized Draft Guidance Documents:
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry (Published 30Apr2020)
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency Guidance for Industry (Published 24Apr2020)
Nonbinding Feedback After Certain FDA Inspections of Device Establishments Guidance for Industry and Food and Drug Administration Staff (Published 22Apr2020)
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry (Published 20Apr2020)
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry (Published 16Apr2020)
Product-Specific Guidances; Guidance for Industry; Availability (Published 14Apr2020)
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products Guidance for Industry (Published 13Apr2020)
Temporary Policy Regarding NonStandard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry (Published 10Apr2020)
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry (Published 09Apr2020)
Investigational COVID-19 Convalescent Plasma Guidance for Industry (Published 08Apr2020)
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act Guidance for Industry (Published 03Apr2020)
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency Guidance for Industry (Published 02Apr2020)
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components Guidance for Industry (Published 02Apr2020)
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry (Published 02Apr2020)
Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria Guidance for Industry (Published 02Apr2020)
New Draft Guidance Documents:
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE (Published 21Apr2020)
FDA lifts drug supply chain security requirements for COVID-19 products (Published 30Apr2020)
View RAPS Article
COVID-19 vaccine tracker (Published 30Apr2020)
EMA explains new pharmacovigilance inspection follow-up procedures (Published 30Apr2020)
EU Regulatory Roundup: Denmark permits remote SDV during COVID-19 pandemic (Published 30Apr2020)
CMDh explains impact of COVID-19 on mutual recognition, decentralised procedures (Published 29Apr2020)
FDA guides generic drugmakers on bioequivalence study disruptions amid COVID-19 (Published 29Apr2020)
FDA, EU authorities update guidance on clinical trials during COVID-19 (Published 28Apr2020)
ICMRA members pledge clinical, regulatory support for COVID-19 products (Published 28Apr2020)
Asia Regulatory Roundup: TGA begins virtual GMP inspections of domestic manufacturers (Published 28Apr2020)
FDA and China’s NMPA expedite COVID-19 emergency approvals (Published 28Apr2020)
Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems (Published 24Apr2020)
Communication During a Pandemic (Published 24Apr2020)
Optimizing remote internal quality audits (Published 23Apr2020)
EMA details new drug supply monitoring system for COVID-19 (Published 21Apr2020)
Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection (Published 21Apr2020)
FDA expands COVID-19 drug compounding policy to smaller pharmacies (Published 21Apr2020)
FDA clarifies policies for reviewing ANDA amendments and supplements (Published 20Apr2020)
EMA updates on regulatory expectations amid COVID-19 (Published 20Apr2020)
COVID-19 IVD quality problems drive EC guidelines (Published 20Apr2020)
FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer (Published 17Apr2020)
NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options (Published 17Apr2020)
EU Regulatory Roundup: EMA shares advice on validated computer systems used in clinical trials (Published 16Apr2020)
Preparing for virtual regulatory meetings (Published 16Apr2020)
Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19 (Published 16Apr2020)
Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies (Published 16Apr2020)
Reagan-Udall Foundation launches COVID-19 treatment hub (Published 15Apr2020)
Harvard professors call on FDA to maintain review standards amid COVID-19 (Published 15Apr2020)
ICH adopts S11 guideline on nonclinical safety testing for pediatric drugs (Published 14Apr2020)
Asia Regulatory Roundup: Industry backs TGA plan to publish applications accepted for evaluation (Published 14Apr2020)
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Decontaminate Millions of N95 Respirators (published 12Apr2020)
Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19 (Published 10Apr2020)
EMA stands up task force to oversee regulatory response to COVID-19 (Published 9Apr2020)
Regulators urge RCTs with control arms for COVID-19 drug trials (Published 09Apr2020)
New system to speed industry-EMA interactions on drug shortages (Published 06Apr2020)
FDA drug review times reflective of 4 key features, GAO finds (Published 06Apr2020)
Why FDA’s Issuance of EUAs are not ‘approvals’ and why that matters (Published 03Apr2020)
ICH: MedDRA updated with supplemental codes for coronavirus (Published 01Apr2020)
- 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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