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Stakeholders Comment on Advisory Committee Session

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Two stakeholders respond to an FDA request for comments on the agencys recent listening session on advisory committees and their g...

Comments Sought on Scheduling for 8 Drugs

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Federal Register notice: FDA seeks comments on the abuse potential, medical usefulness, trafficking, and impact of scheduling chan...

Science Board Meeting on Alternative Methods

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Federal Register notice: FDA announces a 10/7 Science Board Advisory Committee meeting that will hear an update from the new Alter...

Changes Sought in REMS Logic Guidance

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Two stakeholders call on FDA to make major changes to a draft guidance on the REMS logic model that is intended to link program de...

Prednisolone Solution Needs Stability Studies: Petition

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The drug development consulting firm Rahaa asks FDA to require stability studies under refrigerated conditions for generic version...

Accelerated Approval for Gileads Livdelzi

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FDA gives accelerated approval to Gileads Livdelzi to treat some cases of primary biliary cholangitis.

Verrica Positive Data from Skin Cancer Trial

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After reporting preliminary positive results from a Phase 2 clinical trial studying VP-315 in basal cell carcinoma patients, Verri...

FDA Approves Incytes Niktimvo

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FDA approves Incytes Niktimvo for some adult and pediatric host-versus-graft treatments.

Workshop on Measuring Gonadal Toxicity

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FDA and the American Society of Clinical Oncology announce a 10/1 joint workshop entitled Measuring Toxicity in Reproductive Organ...