Regulatory Guidance Monthly Review - March 2021

March 2021 


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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.

 

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New FDA Guidance Documents:

 

COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry March 2021 (Published 04Mar2021)

Download FDA Guidance

 


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

AstraZeneca vaccine deemed safe by EMA, again (Published 31Mar2021)

Read Article on RAPS.org

 

The FDA, prescription drug promotion, and its Bad Ad Program (Published 31Mar2021)

Read Article on RAPS.org

 

Pfizer says COVID-19 vaccine safe, effective for adolescents in trial (Published 31Mar2021)

Read Article on Reuters

 

Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites (Published 29Mar2021)

Read Article on RAPS.org

 

Euro Roundup: MHRA pilot seeks evidence of patient involvement in R&D (Published 25 Mar2021)

Read Article on RAPS.org

 

EC advances amendment to speed adapted COVID vaccines (Published 24Mar2021)

Read Article on RAPS.org

 

FDA recommends 503B bulks list addition; rejects HCQ sulfate (Published 24 Mar2021)

Read Article on RAPS.org

 

Asia-Pacific Roundup: TGA posts guidance to support self-testing for infectious diseases (Published 23Mar2021)

Read Article on RAPS.org

 

HHS hits pause on Trump era SUNSET rule (Published 22Mar2021)

Read Article on RAPS.org

 

FDA’s new integrated review template and implications for regulatory intelligence (Published 22Mar2021)

Read Article on RAPS.org

 

MHRA: In-person inspections to start 29 March (Published 19Mar2021)

Read Article on RAPS.org

 

EMA offers labeling flexibilities for COVID therapeutics (Published 16 Mar2021)

Read Article on RAPS.org

 

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)

Read FDA News Release

 

FDA launches FAERS dashboard for COVID-19 therapies (Published 15Mar2021)

Read Article on RAPS.org

 

Clinical trials, good clinical practice, regulations, and compliance (Published 15Mar2021)

Read Article on RAPS.org

 

Planning for a clinical trial application (Published 15Mar2021)

Read Article on RAPS.org

 

Modernizing clinical trial regulations in Canada (Published 15Mar2021)

Read Article on RAPS.org

 

Orphan product designation requests climb in the US, remain steady in the EU (Published 11Mar2021)

Read Article on RAPS.org

 

Euro Roundup: MHRA sets guidance on importing medicines into Northern Ireland (Published 11Mar2021)

Read Article on RAPS.org

 

FDA’s inspection backlog: GAO raises concerns as delays mount (Published 09Mar2021)

Read Article on RAPS.org

 

FDA sets CDISC implementation timeline (Published 08Mar2021)

Read Article on RAPS.org

 

FDA unveils data modernization plan (Published 03Mar2021)

Read Article on RAPS.org

 

Project Orbis: Maximizing patient access to new medicines (Published 01Mar2021)

Read Article on RAPS.org

 


 

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