The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program ...

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 ...

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 ...

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 ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US FDA taps biotech veteran George Tidmarsh to lead drug center (STAT) (Reuters) A sloppy report on ...

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 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 ...

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 Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Merck gets lift from U.S. patent office in battle over injectable form of Keytruda (STAT) FDA’s AI ...

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is ...

To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website(s) for each country@s ministry of health and regulatory authority. The list is ...

The World Health Organization (WHO) this week began a public consultation on a set of principles and recommendations for good reliance practices (GRelP) in regulatory decision-making aimed at ...