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

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.
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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 ...
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Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives

Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any new ...
RAPS

Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol 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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Regulatory Compliance Certification (RCC)

Validate your Knowledge. Boost your Impact. The Regulatory Compliance Certification (RCC) validates your EU MDR or IVDR knowledge and elevates your credibility in an environment where Europe’s ...
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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 ...
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 ...
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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 ...