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Federal Register notice: FDA posts a final guidance entitled Inclusion of Older Adults in Cancer Clinical Trials.[ Price : $8.95]
FDA approves a Johnson & Johnson Vision Cares Acuvue Theravision with Ketotifen, a drug-eluting contact lens with the antihistamin...[ Price : $8.95]
FDA clears a SurGenTec 510(k) for its Ion Screw and its use as a stand-alone spine fixation implant.[ Price : $8.95]
Attorney Nick Oberheiden lays out a 10-step strategy for companies to use in responding to an FDA Warning Letter.[ Price : $8.95]
FDA grants Pfizer a breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or R...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Master Protocols: Efficient Clinical Trial Design Strategie...[ Price : $8.95]
Four stakeholders make suggestions for an FDA draft guidance on using registries as part of real-world data in drug and biologic r...[ Price : $8.95]
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...