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 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 ...

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 ...

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

RAPS has recognized nine distinguished professionals and one organization with awards for their work to support the regulatory profession and advance public health. Recipients will be honored at RAPS ...

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).

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 ...

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.

Expanded access, also referred to as compassionate use, is a vital pathway for patients with life-threatening diseases to gain early access to unapproved investigational medical devices. This article ...

The US Food and Drug Administration (FDA) on Monday finalized guidance explaining when it considers microneedling devices to be medical devices subject to premarket notification (510(k)) requirements.