Regulatory Affairs Professionals Society

AI in regulatory: Experts say to look beyond validation

As more regulatory professionals adopt artificial intelligence (AI) tools as part of their jobs, a panel of experts who spoke ...
Regulatory Affairs Professionals Society

This Week at FDA: Midterms may complicate Overton confirmation, influence user fee reauthorization, 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, ...
Regulatory Affairs Professionals Society

FDA official expects user fee reauthorization despite midterm shakeup

A top US Food and Drug Administration (FDA) official stated that the midterm congressional election results will not likely ...
Regulatory Affairs Professionals Society

AI won’t erase jobs, but regulatory professionals need to be vigilant, experts say

As artificial intelligence (AI) permeates the regulatory world, experts said it won't take over regulatory professionals' ...
Regulatory Affairs Professionals Society

FDA unannounced foreign inspections in China and India increased in FY 2026

A top US Food and Drug Administration (FDA) enforcement official announced that the agency conducted more unannounced drug ...
Regulatory Affairs Professionals Society

Legal experts: Environmental law can be daunting but having a plan helps

Navigating Europe’s complex environmental and sustainability legislation can be daunting, but healthcare product ...
Regulatory Affairs Professionals Society

Canada’s interim clinical trial policy: What sponsors and investigators need to know

Sponsored Content] Health Canada’s 14 September 2026 interim policy introduces flexibility in ethics reporting, investigator ...
Regulatory Affairs Professionals Society

Stakeholders offer competing feedback on how FDA should regulate genAI devices

More than 500 comments have been submitted in response to the US Food and Drug Administration’s (FDA) discussion paper on ...
Regulatory Affairs Professionals SocietyOpinion

Mifepristone study highlights need for more transparency, data collection in FDA’s REMS program

Patients who reviewed and signed a patient agreement form (PAF) for mifepristone and misoprostol under the US Food and Drug ...
Regulatory Affairs Professionals Society

Recon: Merck KGaA to exit CDMO business; Karyopharm to sell itself in bankruptcy

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
Regulatory Affairs Professionals Society

Recon: FDA approves generic lenacapavir intended for lower income countries; EMA to review Lundbeck's Deanxit for reported serious side effects

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Regulatory Affairs Professionals Society

FDA finalizes cell and gene therapy potency guidance

In a final guidance issued on Monday, the US Food and Drug Administration (FDA) laid out its expectations for cell and gene ...