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

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.

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).

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 ...

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 ...

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 ...

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

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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 ...

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 ...