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CDER researchers say 39% of breakthrough therapy designation requests between 2017 and 2019 were approved by FDA.[ Price : $8.95]
FDA clears a Koru Medical Systems 510(k) for the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes.[ Price : $8.95]
FDA grants Plus Therapeutics an orphan drug designation for rhenium obisbemeda, an injectable radiotherapy for treating breast can...[ Price : $8.95]
FDA releases a final guidance entitled Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using...[ Price : $8.95]
FDA reissues a guidance document entitled Process to Request a Review of FDAs Decision Not to Issue Certain Export Certificates fo...[ Price : $8.95]
FDA clears a Neurovalens 510(k) for its Modius Sleep neurostimulation device for treating chronic insomnia.[ Price : $8.95]
Federal Register notice: FDA determines that Novartis Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn ...[ Price : $8.95]
CDRH says it has recognized and supports industrys use of a key consensus standard "ANSI/AAMI SW96:2023 Standard for medical devic...