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Chief Medical Officer Summit -CMO 360°
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March 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 March 2021.
New FDA Guidance Documents:
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry March 2021 (Published 04Mar2021)
AstraZeneca vaccine deemed safe by EMA, again (Published 31Mar2021)
The FDA, prescription drug promotion, and its Bad Ad Program (Published 31Mar2021)
Pfizer says COVID-19 vaccine safe, effective for adolescents in trial (Published 31Mar2021)
Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites (Published 29Mar2021)
Euro Roundup: MHRA pilot seeks evidence of patient involvement in R&D (Published 25 Mar2021)
EC advances amendment to speed adapted COVID vaccines (Published 24Mar2021)
FDA recommends 503B bulks list addition; rejects HCQ sulfate (Published 24 Mar2021)
Asia-Pacific Roundup: TGA posts guidance to support self-testing for infectious diseases (Published 23Mar2021)
HHS hits pause on Trump era SUNSET rule (Published 22Mar2021)
FDA’s new integrated review template and implications for regulatory intelligence (Published 22Mar2021)
MHRA: In-person inspections to start 29 March (Published 19Mar2021)
EMA offers labeling flexibilities for COVID therapeutics (Published 16 Mar2021)
Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs (Published 16Mar2021)
FDA launches FAERS dashboard for COVID-19 therapies (Published 15Mar2021)
Clinical trials, good clinical practice, regulations, and compliance (Published 15Mar2021)
Planning for a clinical trial application (Published 15Mar2021)
Modernizing clinical trial regulations in Canada (Published 15Mar2021)
Orphan product designation requests climb in the US, remain steady in the EU (Published 11Mar2021)
Euro Roundup: MHRA sets guidance on importing medicines into Northern Ireland (Published 11Mar2021)
FDA’s inspection backlog: GAO raises concerns as delays mount (Published 09Mar2021)
FDA sets CDISC implementation timeline (Published 08Mar2021)
FDA unveils data modernization plan (Published 03Mar2021)
Project Orbis: Maximizing patient access to new medicines (Published 01Mar2021)
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Read our latest news: Veristat Expands Biometrics Capabilities by Acquiring SQN Clinical
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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 Supported Marketing Applications for 10% of all FDA Novel Drug Approvals in 2020
- 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