Jill Wechsler

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

Articles

Regulators Seek More Drug Effects Research Related to Pregnancy and Lactation

Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.

FDA Leaders Seek to Build Public Trust in Science and Gain Support for Regulation

FDA is at a pivotal moment because of important gains in medical treatment based on science.

FDA User Fee Legislation Advances in Senate

Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.

Pharmacists and Manufacturers Rip PBM Practices

Manufacturers are aligning with pharmacists and providers to blame high drug costs and limited patient access on pharmacy benefit managers.

FDA to Continue Inspection Efficiencies After Pandemic

FDA will use virtual site visits even after resuming active inspections.

FDA Moves Forward with State Drug Import Plans

FDA once again is taking steps to facilitate the import of less costly prescription drugs.

New Guidelines Aim to Advance Pediatric Drug Development

A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.

Escalating Abortion Battle Threatens FDA Authority

Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.

Congress Presses FDA on Key Policies and Operations

Members of Congress asked FDA about multiple contentious issues, including expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives.