Jill Wechsler, Pharm Exec’s Washington Correspondent

Jill Wechsler is Pharm Exec's Washington Corespondent


Can Califf Bring Clarity and Enhanced Credibility to FDA?

Word is out that the White House will name cardiologist and research pro Robert Califf to the top FDA job, a position he held for almost a year at the end of the Obama administration. But he may face opposition in the Senate.

FDA, Sponsors Advance Reliance on Real-World Data & Evidence

Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional sources of information into research and approval processes.

Biosimilars Gain Traction with Regulators, Manufacturers

The stars finally may be aligned for Americans to gain greater access to alternative biotech therapies in the coming months.

The Next Big COVID Challenge: Vaccines for Children under 12

If the debate over vaccines for adults and the need for extra booster shots has been heated, FDA will face even more scrutiny over the safety and value of vaccinating children under age 12.

Pharma Blocks Democrats’ Drug Pricing Plan

Democrats failed to gain sufficient support this week to advance long-debated legislation to permit Medicare drug price negotiations.

FDA Moves to Advance Innovative Excipients

FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics.