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Federal Register notice: FDA seeks comments on an information collection extension about a guidance on dispute resolution procedur...[ Price : $8.95]
FDA releases a draft guidance on Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Pediatric Gastroesophageal Reflux Disease: Developing Drugs...[ Price : $8.95]
FDA accepts for priority review an AbbVie NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone...[ Price : $8.95]
FDA clears a Butterfly Network 510(k) for what the sponsor describes as the worlds first ultrasound-on-a-chip based imaging system...[ Price : $8.95]
FDA posts a guidance on De Novo Classification Process (Evaluation of Automatic Class III Designation) that provides recommendatio...[ Price : $8.95]
FDA issues a final guidance document entitled Manufacturers Sharing Patient-Specific Information from Medical Devices with Patient...[ Price : $8.95]
Federal Register: FDA seeks comments on an information collection extension related to a guidance on formal dispute resolution on ...