Jill Wechsler, Pharm Exec’s Washington Correspondent

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.

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.

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.

Critics say FDA is either acting too fast and risking public safety—or too slow, mired in rules while ignoring important scientific findings.

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

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.

FDA’s Vaccines and Related Biological Products Advisory Committee announces its recommendations for the authorization of a third dose of the Pfizer/BioNTech Comirnaty vaccine.

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

But accelerated approval program faces scrutiny.

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