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Guide on Older Adults in Cancer Trials

[ Price : $8.95]

Federal Register notice: FDA posts a final guidance entitled Inclusion of Older Adults in Cancer Clinical Trials.

J&Js Drug Eluting Contacts OKd for Allergy Eyes

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FDA approves a Johnson & Johnson Vision Cares Acuvue Theravision with Ketotifen, a drug-eluting contact lens with the antihistamin...

SurGenTecs Ion Screw Cleared for Spinal Fixation

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FDA clears a SurGenTec 510(k) for its Ion Screw and its use as a stand-alone spine fixation implant.

Strategies for Responding to a Warning Letter

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Attorney Nick Oberheiden lays out a 10-step strategy for companies to use in responding to an FDA Warning Letter.

Breakthrough on Pfizer RSV Vaccine

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FDA grants Pfizer a breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or R...

Oncology Trial Master Protocols Guidance

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Federal Register notice: FDA makes available a final guidance entitled Master Protocols: Efficient Clinical Trial Design Strategie...

Stakeholder Suggestions for FDA Registries RWD Guidance

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Four stakeholders make suggestions for an FDA draft guidance on using registries as part of real-world data in drug and biologic r...

Finch Phase 3 C. Diff Trial Still on Hold: FDA

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FDA says its clinical hold on a Finch Therapeutics Phase 3 trial of CP101 remains in place as the company responds to a request fo...

FDA Finalizes PLAIR Guidance

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FDA publishes a finalized 2013 draft guidance on pre-launch activities importation requests.

Guide on Oncology Expansion Cohorts

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Federal Register notice: FDA makes available a final guidance entitled Expansion Cohorts: Use in First-in-Human Clinical Trials to...