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, ...

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 ...

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 ...

This 4-hour virtual workshop compares FDA, EU, MDSAP, NMPA, MFDS, and PMDA expectations, inspection trends, documentation requirements, and responses to findings, using case studies to strengthen ...

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 ...

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 ...

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 ...

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 ...

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

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

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