FDA

Drug advertisements that the Food and Drug Administration (FDA) believes minimize a product’s risks have long been one…

The Food and Drug Administration seems poised for a busy 2015. The Agency’s Center for Drug Evaluation and Research (CDER) just…

After more than a year of bipartisan work between Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) on…

January 1, 2015 was the initial deadline for manufacturers, wholesale drug distributors, and repackagers to provide…

FDA’s “Purple Book,” which lists all licensed biological products, currently has an empty column under the “biosimilar” heading,…

The Food and Drug Administration (FDA) approved 41 new medicines in 2014, the most since 1996, when the agency approved a record…

2014 has been a big year for healthcare and continuing medical education (CME). Here are ten topics worth going back to that…

In an effort by FDA to project its future areas of focus, the agency has put forth a strategic priorities document for 2014…

OIG Plans to Focus on How FDA Inspects Generic Manufacturers and Enforces Postmarketing and Clinical Trial Transparency…

Whether the FDA considers a product to be a “medical device” as opposed to a “drug” has very important implications.…