Jill Wechsler

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

Articles

Major FDA Reform Unlikely in Closely Divided Congress

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

FDA Embroiled in Reproductive Rights Debate

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 User Fees Reauthorized

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

Pressure Mounts for FDA to Reform Accelerated Approval Program

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.

FDA Expands Oversight of Cell and Gene Therapies

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

Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing

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

FDA Expands Patient Input on Drug Development

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.

Congress Slated to Reauthorize User Fees Without FDA “Improvements”

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.

Clinical Trial Modernization Raises FDA Compliance Issues

Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.