Regulatory

Exagamglogene autotemcel (Exa-Cel) was assigned a Prescription Drug User Fee Act action date of December 8, 2023, for the treatment of sickle cell disease.

Surge acted as a precursor for the RSV-marketed drug landscape in 2023, says GlobalData.

Amy West, Head of US Digital Health & Innovation Strategy at Novo Nordisk, shares her insights on fostering collaboration, embracing change, and her compelling vision to revolutionize digital transformation and innovation in the field of healthcare.

Multiple regulatory pathways exist during the drug development process.

Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry.

The proposed rule is aimed at ensuring the safety and effectiveness of the tests.

The program will offer participants more opportunity to communicate with FDA staff.

Lakdawalla speaks about how drugs aren’t being properly valued.

The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.

Cleve talks about the future of the industry and how data remains a key focus.

Companies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.

The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval.

Drug access leads list of issues raised by pharma shareholders.

Workshop on pharma M&A review and enforcement focuses on what’s not working and what should be on the chopping block.

In this exclusive Q&A, Alice Valder Curran, life sciences regulatory expert and partner, Hogan Lovells LLP, shares her perspective on the biggest drug pricing challenges today, current efforts to lower drug pricing, and the Inflation Reduction Act.

Frederique Welgryn, global vice president for women's health, Perrigo, shares insight into the approval of Opill (norgestrel), a progestin-only contraception, in this exclusive Q&A.

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