FDA

As we noted last week, a group of bipartisan Senators including Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael…

A group of bipartisan Senators including Senators Amy Klobuchar (D-MN), Richard Burr (R-NC),and Michael Bennet (D-CO)…

The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) released last month a new guidance,…

Biologic products developed over the past three decades and approved by the Food and Drug Administration (FDA) now provide…

 The Food and Drug Administration (FDA) announced the publication of a draft guidance titled, “Oversight of Clinical…

This week, the Food and Drug Administration (FDA) announced a revision to its 2006 guidance titled “Marketed Unapproved Drugs--…

 Advertising is a crucial component of pharmaceutical industry marketing around the world and plays an important role in educating…

The Association of Clinical Researchers and Educators (ACRE) today announced its support for reforms to the Food and Drug…

Over the past two years shortages have developed for over 180 drugs, including cancer treatments. According to a recent article…

According to a recent article in the New York Times, “more than 80 percent of the active ingredients for drugs sold in the United…