April 2021
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 2021.
New FDA Guidance Documents:
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry (Published 14Apr2021)
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry (Published 05Apr2021)
New Draft Guidance Documents:
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators DRAFT GUIDANCE (Published 26APR2021)
ICH announces new data exchange with SNOMED to promote drug safety (Published 30Apr2021)
ODAC recommends pulling 2 of 6 accelerated approvals (Published 30Apr2021)
FDA, industry make opening bids in BsUFA III negotiations (Published 29Apr2021)
Regulators discuss expectations and challenges in conducting virtual inspections (Published 29Apr2021)
FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov (Published 28Apr2021)
FDA guidance says sponsors should provide 'convincing' proof of concept data to support INDs for individualized medicine (Published 26April2021)
FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review (Published 23Apr2021)
Time's up for questionable cell and tissue products, says Marks (Published 22Apr2021)
EMA finalizes guidance on parallel MAA, EU-M4all procedure (Published 22Apr2021)
Nitrosamine impurities: Regulatory action in the US, EU, and Canada (Published 21Apr2021)
EU clinical trial portal and database declared functional (Published 21Apr2021)
ICH shares "work-in-progress" update to GCP guidance (Published 19Apr2021)
Rare diseases, STAR expansion considered in PDUFA VII premarket negotiations (Published 16Apr2021)
FDA officials address 'complete assessments' at DMF workshop (Published 12Apr2021)
ATMPs: Global regulators eye harmonization for ultra-orphan products (Published 08Apr2021)
Drugmakers suggest tweaks to FDA’s neurodegenerative disease gene therapy guidance (Published 06Apr2021)
FDA seeks to improve on EUA processes, inspections following PREPP review (Published 02Apr2021)
FDA, EMA team up on pediatric oncology drug development template (Published 01Apr2021)
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Review the recording from our webinar: How to Better Plan Your Virtual Clinical Trial
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Learn how Veristat experts can help you better plan your decentralized clinical trials: Adopting Decentralized Clinical Trials
- Download our COVID-19 Guide on Strategies 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