Jill Wechsler

Congressional measures lack the support to move forward.

Approval of breakthrough therapies requires expedited quality assessment.

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.

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.

Policies limiting imports and immigration generate uncertainty for US and foreign firms

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

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.

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

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.

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.

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

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

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

What’s ahead for the healthcare and pharmaceutical industries?

Reliable, high-quality products require innovative analytics and production.

The biosimilar pathway permits licensure based on less than full clinical data.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.