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 ...
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News & Insights Search

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

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

Recon: Bayer plans for $2.2B manufacturing site in Ohio; FDA’s CDER launches clinical trial modernization office

Food & Nutrition FDA found Cyclospora during Taylor Farms inspection in Mexico (New York Times) (AP News) EU-funded project to develop novel technologies for continuous microbial monitoring in poultry ...
RAPS

Convergence: Regulators highlight efforts to streamline the European regulatory framework

Left to right: Stiina Aarum, Corinne de Vries, Andrea Laslop, Alberto Gañán Jiménez, and Sabine Haubenreisser spoke at RAPS Convergence 2026. (credit: Ferdous Al-Faruque) CHARLOTTE, NC – A panel of ...
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 ...
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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

Asia-Pacific Roundup: TGA starts 5-year transition to new Australian medicine labeling standards

Australia’s Therapeutic Goods Administration (TGA) has adopted two new medicine labeling standards, starting a five-year countdown to mandatory compliance with the updated requirements. The old ...
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Recon: FDA will review generic GLP-1; India floats faster licensing for some devices

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 ...
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Convergence: CBER expert offers tips for effective BLA submissions

CHARLOTTE, NC — When submitting a biologics license application (BLA), it is important to engage with the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) early, make every ...