Building FDA submissions like a solid house requires early collaboration, proactive planning, and a clear regulatory story.

FDA Building 21 stands behind the sign at the campus's main entrance and houses the Center for Drug Evaluation and Research. The FDA campus is located at 10903 New Hampshire Ave., Silver Spring, MD ...

FDA inspection documents reveal systemic contamination issues at ByHeart formula plant as botulism outbreak sickens 37 ...

In this episode, Dr. Marty Makary, Commissioner of Food and Drugs at the FDA, joins the podcast to discuss rebuilding public trust in healthcare, modernizing drug approval processes, improving the ...