Jill Wechsler

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

FDA struggles to track shortages caused by a rise in demand.

Health crises, political tension, and budget concerns were major challenges.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

FDA keeps its user fees but fails to gain important reforms.

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

CBER maps modernization plan to handle surge in research and applications.

FDA backs joint reviews, common research policies, and modern production methods around the world.

FDA is highlighting how the Patient-Focused Drug Development program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.