Jill Wechsler

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


Trump’s Revenge on Pharma

The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.

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

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.

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

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

Stakeholders Seek Increased User Fee Support for Biologics

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

Drug Pricing Back in the Spotlight

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

Will FDA Inspections Ever Be the Same?

Industry should be seeking more information from FDA on how it will restart its current inspection program.

FDA Maps Expectations for COVID Vaccine Proposals

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

Pandemic Spurs Efforts to Boost Pharma Manufacturing in US

FDA can better monitor quality production of domestic versus foreign firms.

FDA Seeks to Restore Credibility with EUA Revocation for HCQ

FDA has revoked its Emergency Use Authorization hydroxychloroquine and chloroquine, citing new evidence and reanalysis of earlier data confirming that the drugs show no evidence of effectiveness against the coronavirus and raise continued concerns about cardiovascular safety risks.

Fauci States that Industry Will “Walk Away” from Price Controls

Will efforts to limit all returns on investment drive biopharma companies away from developing much-needed interventions for COVID-19.