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FDA grants Carthera a breakthrough device designation for its SonoCloud-9 system, a device that uses low intensity pulsed ultrasou...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Protection of Human Subjects; Informed...[ Price : $5.00]
Federal Register notice: FDA makes available a draft guidance entitled Considerations for Rescinding Breakthrough Therapy Designat...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Prev...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Assessing the Effects of Food on Drugs in INDs and NDAs Cl...[ Price : $8.95]
FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeu...[ Price : $8.95]
FDA publishes a draft revising a 2013 guidance on a CGMP framework for preventing cross-contamination in non-penicillin beta-lacta...[ Price : $8.95]
FDA says the Baxter Healthcare recall of its Volara system due to risk of respiratory distress in home use is Class 1.