'Accelerated approval' presentation slideshows

Washington Representatives Retreat (Day 1)

Washington Representatives Retreat (Day 1). November 30 - December 1 Loews Annapolis Hotel 126 West Street, Annapolis, MD. 21st Century Cures Act: Pharmaceutical & Biologics Provisions 2017 Washington Representatives Retreat November 30- December 1, 2017. David B. Clissold. Background.

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Defining Success in Oncology Drug Development

Defining Success in Oncology Drug Development. Richard Pazdur, MD CDER, FDA The views expressed are the results of independent work and do not necessarily represent the views or findings of the United States Food and Drug Administration or the United States. Basis for NDA Approval.

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Meeting the Challenge of Pandemic Vaccine Preparedness: FDA Perspectives

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News from the FDA Approvals through June 2003

Pharmacophilic minutes. News from the FDA Approvals through June 2003. Emend (aprepitant). March 26, 2003 Approved for use in combination with other anti-nausea and anti-vomiting drugs for delayed N&V associated with initial and repeat courses of chemotherapy.

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Four Special Channels for FDA to Review Drugs

Recently, the FDA awarded the patent-based enfortumab vedotin antibody-conjugated drug developed jointly by Seattle Genetics and its partner Astellas. The drug is currently in a phase II study of a key metastatic transitional cell carcinoma. This is undoubtedly a good news for Seattle Genetics. They have also marked the project with a "breakthrough therapy" label. After the first commercial product, Adcetris, this is the company's most promising ADC drug. Enfortumab vedotin consists of an anti-Nectin-4 monoclonal antibody and Seattle's own synthetic cytotoxin monomethyl auristatin E (MMAE), which is the first ADC drug to target solid tumor Nectin-4, targeting bladder cancer.

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Topics for Discussion

Topics for Discussion. 1. Regulations allow granting regular or accelerated approval

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