Postmarket clinical follow-up (PMCF) surveys are a proven method for collecting the data used for EU Medical Device Regulation (EU MDR) submissions, but there is limited guidance on survey procedure ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Senators reveal how much Lilly, Pfizer paid telehealth companies (STAT) FDA advisers vote against ...

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, the ...

The top official at the US Food and Drug Administration’s (FDA) drug center is retiring after almost a decade at the agency. On 23 June, Jacqueline Corrigan-Curay, acting director of the Center for ...

Most pivotal clinical trials supporting the accelerated approval of nononcology products reported surrogate measures as primary endpoints, according to a recent research letter published in JAMA.

Utah Chapter Event: Potluck in the Park 2025 - Connecting in Nature! Thursday, 31 July 2025 5pm to 8pm Come mingle with your regulatory colleagues and friends in the relaxed atmosphere of Sugarhouse ...

The US Food and Drug Administration (FDA) recently issued its third warning letter under the Drug Supply Chain Security Act (DSCSA) to Florida-based Sterling Distributors for multiple violations, ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid the groundwork for the implementation of new clinical trial regulations in April 2026 by publishing a series of guidelines.

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, we ...

The US Food and Drug Administration (FDA) has announced that it will give drugmakers more time to conduct testing for nitrosamine drug substance-related impurities (NDSRIs) in approved pharmaceuticals ...

Former US Food and Drug Administration (FDA) official Peter Marks critiqued the lack of public review in the agency@s recent COVID-19 vaccination policy in a New England Journal of Medicine article ...

The practice of a brand manufacturer delaying the launch of an authorized generic medication has declined over recent years, and its effects on the market can be both positive and negative depending ...