Category: FDA

FDA Chief and HHS Secretary Cite Prescription Drug Prices as Top Priorities for Agencies; President Trump Scheduled to Speak on Issue on May 11, 2018.

Nicole Burgmeier

All eyes are on the federal government as top officials have recently signaled upcoming actions which could impact the prices of prescription drugs. In the past two weeks, leaders from both the FDA and HHS have made statements signaling that the agencies are focused on reducing prescription drug prices. In remarks at the Food and...

FDA Requests Painkiller Removed From the Market

Grace Fleming

The FDA has called on the drugmaker Endo Pharmaceuticals to stop selling the opioid Opana ER. The press release on June 8th reflecting this announcement marks a novel approach from the FDA, as the agency for the first time has asked a company to remove a painkiller from the market based on the public health...

FDA Issues Three New Rules Under the Food Safety Modernization Act

Robert G. Hensley

November 16, 2015 On November 13, 2015, the U.S. Food and Drug Administration (FDA) published three final rules issued under the Food Safety Modernization Act.  The new rules are: (1) the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule), (2) the Foreign Supplier Verification Programs (FSVP) Rule...