Regulatory Affairs Professionals Society

MHRA announces strategy to streamline regulation in the AI era

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring ...
Regulatory Affairs Professionals Society

FDA seeks input on studying psychedelic ibogaine

The US Food and Drug Administration (FDA) is seeking public input on how to design early-phase clinical trials to evaluate ...
RAPS

Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight European countries

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
RAPS

Experts weigh in on FDA’s transparency roadmap

The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and its priorities for FY 2027. Two key priorities for the future include a ...
RAPS

Biosimilars: FDA finalizes guidance on postapproval manufacturing changes

The US Food and Drug Administration (FDA) last week finalized its guidance on postapproval manufacturing changes for biosimilars to better align with international guidelines and to better address ...
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Recon: Bayer plans for $2.2B manufacturing site in Ohio; FDA’s CDER launches clinical trial modernization office

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
RAPS

FDA’s device center releases guidance agenda for FY 2027

Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug ...
RAPS

MHRA adopts AI framework proposed by UK docs

The Medicines and Healthcare products Regulatory Agency (MHRA) says the UK government has adopted a list of recommendations on the use of artificial intelligence (AI) in medical devices developed by ...
RAPS

WHO drafts updated guideline on quality risk management

The World Health Organization (WHO) has issued an updated draft guideline to assist manufacturers establish an effective quality risk management (QRM) system and to help regulators in planning their ...
RAPS

This Week at FDA: No Overton vote until after midterms, FDA signals advisory committee support, and more

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, we ...