Regulatory

As we approach the one-year anniversary of the IRA being signed into law, questions remain about how the new law will reverberate changes across the biopharma industry.

The more serious shortages commonly involve sterile injectables.

Newly-issued final guidance focuses on language used when communicating quantitative efficacy or risk information.

Pharma is built to overcome, but focus on fundamentals remains key.

First guidance in this area from the Agency addresses the unique challenges when designing clinical studies for these drugs

Could feel the impact from potential new provisions to legislation reauthorizing US international health programs.

New program seeks to reduce misuse and adverse reactions by simplifying prescription labels.

New federal law introduces significant changes in the design of pharmacy benefit plans with aims to level the playing field between PBMs and their employee healthcare benefit plan clients.

Areas of focus during phase-out include telehealth and patient access.

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.

Taking stock as the Orphan Drug Act hits its 40-year anniversary.

At Pharma USA 2023, Peter Marks, MD, PhD and director of CBER described FDA and public/private partnerships working toward scalable manufacturing approaches to address commercial viability and global access for cell and gene therapies

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

Region’s diversity plays against efforts to curtail counterfeit drugs.

New candidates are targeting cancer, infectious diseases, and RSV.

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.