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Federal Register Notice: FDA and Johns Hopkins University Center of Excellence in Regulatory Science and Innovation announce a 11/...[ Price : $8.95]
Federal Register Notice: FDA issues a priority review voucher to Sarepta Therapeutics after determining its NDA for Duchenne muscu...[ Price : $8.95]
Virtus Pharmaceuticals files suit against FDA in middle Florida federal court seeking an order barring enforcement action against ...[ Price : $8.95]
Leonhard Lang begins a Class 1 recall of its multi-function defibrillation electrodes DF29N because they will not work with Welch ...[ Price : $8.95]
FDA tells Egalet Corp. that it will not meet a previously announced 10/14 user fee review target date for the pain drug Arymo ER (...[ Price : $8.95]
FDA announces a 10/21 public meeting to hear public comments on the recent proposed agreement to reauthorize the generic drug user...[ Price : $8.95]
FDA clears a Royal Philips 510(k) for the S4-1 cardiac transducer for Lumify, asmart-device diagnostic ultrasound solution.[ Price : $8.95]
FDA releases a guidance on ANDA Submissions Prior Approval Supplements Under GDUFA that is intended to assist applicants preparin...