The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2026 across its prescription drug, generic drug, biosimilar, and medical device programs. The rates are ...

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 ...

Supply chain experts said that most manufacturers successfully implemented the enhanced tracing requirements outlined in the Drug Supply Chain Security Act (DSCSA) by the 27 May deadline without ...

This course provides an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field.

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

On 18 July, Mexico@s health ministry took a leap toward harmonization of regulatory requirements for medicines, publishing new guidelines that allow its medicines agency to honor decisions by ...

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 ...

Sprout Pharmaceuticals@ promotion of Addyi both mischaracterizes the drug@s indication and downplays potential serious adverse events associated with its use, according to a warning letter from the US ...

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 ...

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 ...

This event covers innovative approaches to create new technologies for medical devices and life sciences, launch innovative projects, and start ventures.

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 ...