Regulatory Watch

October 01, 2024

Regulators, EMA and HMA, have published principles and recommendations on the use of LLMs, which are being increasingly used for daily tasks.

December 02, 2023

FDA and industry face unprecedented political and policy challenges.

August 02, 2023

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

July 02, 2023

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

June 02, 2023

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

May 02, 2023

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

April 02, 2023

FDA has spurred investment to create and develop 600 therapies.

March 02, 2023

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

February 02, 2023

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

January 02, 2023

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