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Near-unanimous adcomm nod on Pfizer COVID vaccine for younger kids
26 October 2021
Though the vote tally would indicate robust endorsement from the committee, the day’s presentations and discussions unfolded a more nuanced picture, with lingering concerns about a signal for myocarditis and pericarditis in older adolescents and y...

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European Commission identifies 10 ‘promising’ COVID treatments
26 October 2021
The European Commission (EC) on 22 October released a list of the 10 “most promising treatments” for COVID-19 as part of its strategy to support the development of new therapies.  
CDRH outlines guidance plans for FY2022
26 October 2021
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released its list of guidances it intends to issue or finalize in FY2022, with new guidances planned and some documents making repeat appearan...
Asia-Pacific Roundup: TGA mulls mandating medical device adverse event reporting by healthcare facilities
26 October 2021
Australia's Therapeutic Goods Administration (TGA) is seeking feedback on plans to make it mandatory for healthcare facilities to report adverse events linked to medical devices. Currently, only manufacturers and sponsors need to report adverse ev...

Latest Features

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September’s Regulatory Focus: Diversity in regulatory affairs, clinical trials, and more

07 October 2021

Strengthening the regulatory profession through resilience and diversity

30 September 2021

Strategies for managing regulatory risk with third-party distributors

30 September 2021

 

RF Quarterly

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RF Quarterly, October 2021: Quality and compliance

04 October 2021

Data integrity and compliance with GxP: A pragmatic approachMember only

04 October 2021

Current good manufacturing practices and quality system designMember only

04 October 2021

  RECON
Recon: WHO review of India's Covaxin underway; Novartis mulls spinoff of generic unit Sandoz

26 October 2021

Recon: FDA staff say Pfizer vaccine's benefits outweigh risks in kids ahead of adcomm; Biden meet with Califf as commissioner search narrows

25 October 2021

  ROUNDUPS
Asia-Pacific Roundup: TGA mulls mandating medical device adverse event reporting by healthcare facilities

26 October 2021

Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions

21 October 2021