Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.

Jill Wechsler

Articles

A new FDA guidance provides answers to such questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

FDA May Delay Approval of Drugs Where Necessary Inspection Is Not Feasible

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally. 

Global Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs

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

Stakeholders Seek Increased User Fee Support for Biologics

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation? 

Author | Jill Wechsler

Articles