Manufacturers Face Challenges and Regulatory Changes

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

FDA and industry face unprecedented political and policy challenges.

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

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

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

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