Regulatory

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

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.

Addresses a host of issues and policy priorities impacting pharma.

Is agenda blurring the line between alliances and assimilation?

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

The Caremark and Park doctrines require directors and managers of life sciences companies to address regulatory compliance proactively and vigorously.

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.

The parameters governing pharma promotional speech in digital and social media have struggled to keep pace with the rapidly evolving healthcare communications landscape. How can FDA play catch-up in advancing an agenda more reflective of industry and patient needs?

Member states air concerns over excess supplies of COVID vaccines.

2023 is poised to deliver a new set of challenges.

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

Regulation revision now allows pharmacies to dispense mifepristone directly to individuals with a prescription.

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

Current virus “triple whammy” taxes supply levels, while raising concerns over FDA’s limited power to track drug demand spikes.

No shortage of views being expressed on drug shortages.

Year characterized by mix of key advances, contentious stances.

Better technology is redefining pharmacovigilance as it expands beyond its traditional compliance focus to become a key business differentiator.

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

Virtual audits proving to be beneficial post-COVID despite continuing challenges.

Making sense of surprise rejection of draft proposals.

Agency under pressure from both sides—and potential congressional changes could complicate the issue further.

Potential drug removal spotlights latest debate over the expedited pathway.

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