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

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

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 ...
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 ...
RAPS

Asia-Pacific Roundup: Japan’s PMDA shares guidance on assuring safety in generic bioequivalence studies

The Pharmaceuticals and Medical Devices Agency (PMDA) has published advice on ensuring the safety of healthy adult participants in Japanese bioequivalence studies. Published as part of the “early ...
RAPS

Study: Growing patent thickets may hinder generic competition

Over the last 15 years, there has been an uptick in the number of patents associated with small-molecule drugs approved by the US Food and Drug Administration (FDA), with a majority of the increase ...
Regulatory Affairs Professionals Society

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 ...
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 ...
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

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 ...