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.