Regulatory Affairs Professionals Society

MDUFA VI: Draft commitment letter details enhancements, performance goals

The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical ...
RAPS

This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, 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 proposes rule to ease registration for distributed manufacturers, require foreign API sites to register

The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing ...
Regulatory Affairs Professionals Society

FDA plans rules to rein in drug ads, enable proactive release of CRLs, and more

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...
Regulatory Affairs Professionals Society

Recon: FDA denies Hengrui-Elevar liver cancer drug for the third time; GSK to pursue FDA nod for Jemperli for rectal cancer

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

FDA admonishes companies for marketing unauthorized products, making misleading claims

The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices ...
RAPS

Experts: Ending adequate provision would shut down prescription drug ads

The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the high ...
Regulatory Affairs Professionals Society

Asia-Pacific Roundup: India cuts prices of more than 30 drugs and biologics

India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological ...
RAPS

CDER plans new guidance on AI, electronic safety report submissions, and more

CDER plans new guidance on AI, electronic safety report submissions, and more FDA headquarters in White Oak, Md. (Credit: Ferdous Al-Faruque) The US Food and Drug Administration’s (FDA) Center for ...
RAPS

Tampons: FDA toxicological study finds negligible levels of toxic metals

Researchers at the US Food and Drug Administration (FDA) recently conducted a study in response to a 2024 study that raised safety concerns about metal toxicity from tampons; however, the study found ...