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, ...
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 ...
RAPS

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 ...
RAPS

North Carolina LNG In Person Event- Inside FDA ASCA: Practical Insights

The RAPS NC Local Networking Group presents an in-person FDA ASCA Program session focused on the appropriate use of standards, conformity assessment, and practical strategies for premarket submissions ...
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

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

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

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

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 ...