Jill Wechsler

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.

CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.

Congressional measures lack the support to move forward.

Approval of breakthrough therapies requires expedited quality assessment.

User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

The role of patient advocates in shaping regulations and policy has put attention on financial and operational links between drug companies and independent health organizations.

FDA is in the center of the debate over developing and pricing new cancer therapies.

Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.

Industry fears limited benefits as FDA readies voluntary data tracking program.

A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.

Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.

President Trump calls for faster FDA approvals and lower drug prices.

Manufacturers face uncertainty over imports, regulatory policies, and field inspections.

FDA plans to initiate its quality metrics program as industry continues to push back.

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.

In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.

User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.

FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.

FDA published a flurry of guidance documents in late 2016.

FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.

Congress enacted the 21st Century Cures legislation, which shores FDA operations and supports biomedical research at the National Institutes of Health.

The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.

Republican control of Washington promises overhaul of healthcare and medical product regulation.

Biopharma proponents argue for FDA resources, Cures legislation, and science-based drug regulation.