Columns | View from Washington

Agency will be reorganizing field force and compliance functions.

Agency seeks added resources and new approaches to accelerate more of these promising treatments to the market.

The Supreme Court’s emergency action maintaining access to mifepristone fails to protect agency from future rulings that could subvert drug approval process.

Legal experts: Ruling on abortion pill could spur challenges involving other authorized medical products.

Impact areas that will be closely watched during phase-out include drug testing and authorization, telehealth, and patient access.

The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.

Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.

Probe targets agency’s role in advising on drug testing and submissions.

With industry’s uneven track record in patient representation, sponsors now mandated to submit Diversity Action Plans (DAPs) to FDA for Phase III and pivotal studies.

Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.

Face-to-face meetings will now include in-person and virtual components.

Agency panel backs the use of a common bivalent shot for all patients.

House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.

The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.

Looking back on major FDA moves in 2022.

Following closely contested election, approval of FDA bills most likely tabled until new year.

Potential drug removal spotlights latest debate over the expedited pathway.

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

The ‘skinny’ user fee reauthorization tables multiple high-profile proposals.

Agency releases a series of new guidances to advance the reliability of patient-focused tools and methods.

Seek pared-down measure in funding bill to avert shutdown.

Agency officials express associated concerns around clinical trial data reliability and quality.

Administration launches national manufacturing initiative, with aim to reduce US reliance on biomedicine from China and other regions.

In countdown to renewal deadline, agency already feeling the effects of still-unclear legislative fate.

Pharma loses battle to block price negotiations, but implementation faces many challenges.

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Citing strong reporting results, hybrid model to continue supplementing on-site inspections.

With debate swirling around products cleared through this pathway, reforms and tighter oversight likely.

With the renewal deadline looming—and disagreement still swirling on enhancing FDA authority—a counter proposal calls for a streamlined, fee-only bill.

Amid push to include this population more in clinical trials, the goal is to uncover improved evidence on the risks/benefits of drugs for these patients.