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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

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

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

Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VI

Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry ...
RAPS

Recon: Biogen reports mixed results for Alzheimer’s tau drug; AstraZeneca to license Dizal’s lung cancer drug

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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Psychedelics: FDA offers clarifications, compromises in final clinical trial guidance

In the draft version, FDA said sponsors should plan to characterize the durability of response for their drug product, the recommended inter-dose interval for maintenance of effect, and the safety and ...
RAPS

FDA warns drugmakers over contamination controls, inadequate investigations

The US Food and Drug Administration (FDA) recently issued two warning letters to a sterile drug manufacturer and an over-the-counter (OTC) drug maker in the US for multiple violations of good ...
RAPS

FDA finalizes guidance on formal meetings with OTC sponsors

The US Food and Drug Administration (FDA) on Monday released final guidance detailing the procedures for holding formal meetings between sponsors of over-the-counter (OTC) monograph drugs and the ...
RAPS

RAPS Awards Program

Honoring excellence. Celebrating leadership. Advancing the profession. The RAPS Awards Program recognizes and celebrates regulatory professionals who demonstrate exceptional commitment, innovation, ...