Author | Jill Wechsler

Jill Wechsler is Pharm Exec's Washington Corespondent


Stakeholders Seek Increased User Fee Support for Biologics

July 24, 2020


Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

Will FDA Inspections Ever Be the Same?

July 20, 2020


FDA's plans to resume inspections of some US regulated facilities this week are not clear on which sites will be visited and what alternative oversight strategies will apply where on-site inspections are difficult.

FDA Maps Expectations for COVID Vaccine Proposals

July 09, 2020


The FDA has released a new guidance which outlines recommendations for quality and safety in potential COVID vaccines as they move through trials.

Fauci: Industry Will ‘Walk Away’ From COVID Price Controls

July 07, 2020

Pharmaceutical Executive


Stresses the need for fair pricing of therapies, while ensuring access.