Jill Wechsler

Unprecedented policy and access issues threaten R&D momentum.

The more serious shortages commonly involve sterile injectables.

Areas of focus during phase-out include telehealth and patient access.

Taking stock as the Orphan Drug Act hits its 40-year anniversary.

COVID vaccine development highlights need for modernization.

Sweeping competition initiative drills in on cost reduction.

In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill patients based on early clinical results, Richard Pazdur, director of FDA’s Oncology Center of Excellence, lashed out at the alarmists and urged continued support for this early access process.

White House backs big boost in funding for research, public health.

An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill in anticipation of gaining approval in the coming year.

Separate pushes for vaccine equity, legislation to lower drug costs.

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

Public health authorities and the biomedical research community are seeking new strategies to address global health threats, writes Jill Wechsler.

The agency hopes to better use global resources and avoid duplicate inspections of foreign facilities.

Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.

Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.

President Trump calls for faster FDA approvals and lower drug prices. Jill Wechsler reports.

January 25, 2017