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ISPOR Panelists: Can the FDA Advisory Committee Process Be Strengthened?

Panelists at the leading health economics and outcomes conference discuss whether the FDA's process for allowing outside experts to weigh in on drug approvals needs changes. ....

United States , Emory University , Joseph Daval , Genevieve Kanter , David Howard , Medicare Evidence Development , Rubix Health , Society For Health Economics , University Of Southern California , Outcomes Research , Medicare Advisory Committee , Advisory Committee , Program On Regulation , Coverage Advisory Committee , Harvard University , Professional Society , Health Economics , Chief Counsel , Image Credit , Affordable Care Act , Fda Advisory Committee ,

'Substantial uncertainty' about clinical value of most accelerated approval cancer drugs

'Substantial uncertainty' about clinical value of most accelerated approval cancer drugs
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San Diego , United States , Edwardrs Cliff , Bydrew Amorosi , Mindy Valcarcel , Program On Regulation , American Association For Cancer Research Annual Meeting , Harvard Medical School , Journal Of The American Medical Association , American Association , Cancer Research Annual Meeting , American Medical Association ,

In 5-Year Span of FDA Accelerated Approvals in Cancer, 43% Show Confirmatory Clinical Benefit

Fifty-seven percent of drugs granted accelerated approval for a cancer indication showed clinical benefit in confirmatory studies. ....

San Diego , United States , Selpercatinib Retevmo , Edwardrs Cliff , Bosutinib Bosulif , Capmatinib Tabrecta , Asciminib Scemblix , Program On Regulation , Harvard Medical School , American Association For Cancer Research , Than Half , Confirmatory Trials After Five , American Association , Published April ,

Direct-to-Consumer Drug Company Pharmacies

The recent launch of direct-to-consumer pharmacy LillyDirect prompts the author of this Viewpoint to consider why it was created and also to raise concerns abou ....

United States , Mark Cuban , Eli Lilly , Department Of Medicine , Elevance Health Public Policy Institute , National Academy For State Health , Novo Nordisk , Division Of Pharmacoepidemiology , Prescriber Network , Program On Regulation , Inflation Reduction Act , Interest Disclosures , Arnold Ventures , National Academy , State Health Policy ,

Patents on Risk Evaluation and Mitigation Strategies for Prescription Drugs and Generic Competition | Health Care Economics, Insurance, Payment | JAMA

This cross-sectional study identified the prevalence of patents on risk evaluation and mitigation strategies and their association with delaying generic competi ....

United States , Jodyw Zylke , Karen Lasser , Kristin Walter , Program On Regulation , Drug Administration , Commonwealth Fund , Virginia University Hodge Research Grant , Orange Book , Deputy Editors , Ameet Sarpatwari , Interest Disclosures , West Virginia University Hodge ,