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FDA (2)
When is a Drug or Device Misbranded?
The Federal Food, Drug, and Cosmetic Act ("FDCA") is a federal law that is a primary source for many rules that impact the pharmaceutical and medical device industries. The FDCA's intent...
Medical Device Reports (MDRs)
The Food and Drug Administration ("FDA") requires medical device companies to report fatal or serious incidents - or potentially fatal or serious incidents - associated with the use of...
What are the best practices for dealing with FDA inspections?
Question: What are the best practices for dealing with FDA inspections? Answer: Many life sciences companies may regard the prospect of an FDA inspection with dread, in part because...