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Set Alert for US

340B Drug Diversion: Sanofi Suit Seeks Evidence In Pharmacy Contracts With Hospitals

Drug maker pursuing novel approach to establishing that contract pharmacies are improperly taking ‘title’ to 340B-discounted drugs, leading to diversion, which is prohibited by law.

Pricing Debate Legal Issues

Anti-Globalism Policy Cannot Stifle International Cooperation, US FDA’s Califf Says

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

DIA Supply Chain

Biosimilars: US FDA Heralds The End Of Switching Studies For Interchangeability

New guidance suggests that switching studies will no longer be expected as standard to support determinations of biosimilar interchangeability; instead, analytical and clinical data may suffice.

Biosimilars Guidance Documents

US FDA Vaccine Approvals Set Up CDC Votes On Merck’s Capvaxive, Moderna’s mResvia

Advisory Committee on Immunization Practices expected to vote 26-28 June on use of Merck’s 21-valent pneumococcal vaccine, Moderna’s mRNA vaccine for RSV, and an expanded age range for GlaxoSmithKline’s Arexvy RSV vaccine.

Approvals Vaccines

Advisory Committees: US FDA Should Explain Divergent Decisions But Keep The Vote

Agency should be more proactive in issuing communications after advisory committee meetings, stakeholders advised; public interest group and industry representatives said the voting process is important for transparency and accountability.

Advisory Committees Drug Review

US FDA Creating Rare Disease ‘Hub’ To Serve As Center Of Excellence

While not brandishing the name advocates have pushed for many years, the rare disease hub will play much the same role as a center of excellence in increasing collaboration between experts in the FDA drug and biologics centers.

DIA Rare Diseases

Global Governments ‘Neglecting’ Vaccine Investment Post-COVID

Seth Berkley, epidemiologist and former CEO of Gavi, the vaccine alliance, has emphasized the importance of making “investments in peacetime” to prepare for pandemic threats and called for a “mindset change” among global governments.

United Kingdom BioPharmaceutical

PDUFA VIII: Continuous Fee Increases May Be Wearing On Sponsors

A Pfizer exec says that the old prescription drug user fee formulas that usually increase funding and staffing for many FDA programs no longer deliver the same return on investment.

User Fees Drug Review

Flat-Lining US FDA: Failure To Invest May Have Consequences

Old habits die hard when it comes to funding the FDA. When the agency is doing things well, it doesn’t get the money it needs to keep up the momentum. 

Legislation User Fees

CAR-T Therapies: Access Considerations May Influence US FDA's Efficacy Evaluation

CBER's Lola Fashoyin-Aje offers some thoughts on when and how the FDA might consider the accessibility of a product in its approval decisions at BIO 2024.

Drug Approval Standards Clinical Trials

US FDA User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike

With likely more fee-paying applications arriving at the agency, sponsors may be wondering whether user fees should have been increased as much as they were at the start of FY 2024.

User Fees Drug Review

AI and Adverse Events: Tech Not Ready For Prime Time For Case Safety Reports, US FDA Says

FDA leadership weighs in on limitations of AI as part of rollout of new technology meeting program that looks to give industry and other stakeholders a chance to inform future regulation.

Artificial Intelligence Drug Safety

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Coronavirus COVID-19 Vaccines

SCOTUS' Mifepristone Decision Sets High Bar For US FDA Suits, But Risks To Agency Authority Linger

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.

Drug Safety Legal Issues

US NIH And Drug Pricing: Still Seeking A Balance

“Access Plans” are the US NIH’s new idea to address calls to take a more hands-on role in regulating the prices of products developed with taxpayer funding, but what the policy would actually mean for prices is hard to pin down, and that is probably deliberate.

Pricing Debate Legal Issues

Advisory Committee Consumer Reps Often Fail To Represent Consumer Interests, Groups Tell US FDA

Many positions are vacant or filled by individuals with ties to academia, industry or patient groups, representatives from public interest and consumer groups say during an FDA listening session on advisory committee reforms.

Advisory Committees FDA
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