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 ...

FDA also chastised the company for its failure to conduct stability testing program for its drug products in a timely manner. FDA said that “stability testing was overdue by 3 months or longer for a ...

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 ...

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 ...

340 Global Regulators, Health Authorities and Industry Partners Gather in Sydney for Australia Regulatory Device Summit 2025 RAPS Announcements | 21 July 2025 | RAPS ...

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 ...

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.

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 ...

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 ...

The Central Drugs Standard Control Organization (CDSCO) has shared guidance on obtaining a certificate to export new drugs from India. @ ...

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 ...

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 ...