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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.

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

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.

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

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