Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US FDA chief’s goals of ‘radical transparency’ threatened by agency cuts (STAT) Eli Lilly drug ...

The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to comply with the agency@s postmarket ...

The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of ...

Many of the concepts and programs the agency discussed with the pharmaceutical industry during the months of reauthorization negotiations have made it into the newly published commitment letter.

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 ...

Singapore@s Health Sciences Authority (HSA) is running a consultation into plans to exempt more types of artificial intelligence (AI)-software as a medical device (SaMD) products from its license and ...

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 US Food and Drug Administration (FDA) on Friday approved the first new molecular entity as part of an international collaborative review effort dubbed Project Orbis.

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 ...