Michael Mezher

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. Th...

The US Food and Drug Administration (FDA) on Monday published a letter to Chinese medical device testing firm Mid-Link Technology Testing advising the company that all data from its studies wi...

After canceling a routine meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the composition of the 2025-2026 influenza vaccine, the US Food and Drug...

After canceling a routine meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the composition of the 2025-2026 influenza vaccine, the US Food and Drug Administration (FDA) on Thursday announced its recommendations for strain selection following a closed-door meeting with other government agencies.

The US Food and Drug Administration (FDA) on Tuesday announced it will expand its effort to conduct unannounced inspections of foreign manufacturing facilities that produce medical products an...

The Trump Administration is seeking $6.8 billion to fund the US Food and Drug Administration (FDA) in FY 2026 – an 11.5 percent cut from its current budget authority – with the agency looking ...

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

The US Food and Drug Administration (FDA) on Friday began the reauthorization process for the next iteration of the Generic Drug User Fee Amendments (GDUFA IV) with a public meeting to gather ...

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 we...

The healthcare product landscape in Europe is undergoing significant transformation—from multiple legislative overhauls to the rapid adoption of artificial intelligence (AI) and other boundary-pushing technologies. For regulatory professionals attending RAPS Euro Convergence 2026 in Lisbon, the meeting is an opportunity to lean into community to stay on top of the myriad changes coming their way.