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.

The UK government has announced an ambitious plan to become the leading life sciences economy in Europe in five years and the third most important global life sciences economy by 2035. The plan ...

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) has published the user fee amounts it will collect in FY2023 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and ...

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 ...

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 ...

To reduce the risk of aluminum toxicity in infants and adults with impaired renal function, the US Food and Drug Administration (FDA) has issued revised draft guidance to help manufacturers minimize ...

The European Commission wants feedback from stakeholders on updating its good manufacturing practice (GMP) guidelines in EudraLex Volume 4 to account for recent advances in artificial intelligence (AI ...

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.

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 ...