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 US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) this week released a white paper aimed at encouraging the use of selective safety data collection (SSDC).

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.

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 ...

Recon: Sarepta resumes shipments of Elevidys for ambulatory patients; Merck to cut costs by $3B Recon | 29 July 2025 | Jason Scott ...

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 ...

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 ...

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

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 ...

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.

A European Parliament committee has proposed changing the draft Critical Medicines Act (CMA) to reflect the impact environmental measures have on drug supply.