Michael Mezher

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 Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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 ...

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...

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...

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...

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 International Medical Device Regulators Forum (IMDRF) on Wednesday finalized two highly anticipated technical documents detailing guiding principles for good machine learning practices (GM...

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’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Merz Pharmaceuticals concerning a recent paid Instagram post promoting its Botox c...

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. There@s a lot to unpack from the past week @ the election of Donald Trump to serve a second term as president has massive implications for both FDA and the regulated industry, though despite some incendiary comments about what@s to come, much remains to be seen about how the incoming administration will act.

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...

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...

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...

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 wants stakeholder feedback on its integrated assessment and integrated review documentation for new drugs as part of its New Drugs Regulatory Program Modern...

India’s Central Drugs Standard Control Organization (CDSCO) earlier this month announced that it will waive local clinical trial requirements for certain drugs approved in other countries.

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

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

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