Regulatory Affairs Professionals Society

FDA launches rare disease framework initiative

A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to ...
Regulatory Affairs Professionals SocietyOpinion

Experts favor a new regulatory framework for clinical AI models

Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic ...
Regulatory Affairs Professionals Society

FDA warning letters raise concerns about CGMP, GLP violations

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet ...
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

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

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

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

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 ...