Regulatory Beat

September 28, 2023

The agency will be reorganizing field force and compliance functions.

August 01, 2023

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

July 01, 2023

Problems continue despite actions by regulators to better prevent and address drug shortages.

June 01, 2023

An increase in applications for gene therapies is putting stress on FDA’s resources.

May 01, 2023

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

April 01, 2023

FDA has spurred investment to create and develop 600 therapies.

March 01, 2023

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

February 01, 2023

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

January 01, 2023

Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.

December 01, 2022

Health crises, political tension, and budget concerns were major challenges.