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Sandoz petitions FDA asking that it not approve generic copies of GlaxoSmithKlines asthma inhaler Advair Diskus 100/50 unless ANDA...[ Price : $8.95]
FDA reviewers question clinical trial designs in a Serenity Pharmaceuticals NDA for SER120 (desmopressin nasal spray), which is pr...[ Price : $8.95]
Omnicare agrees to pay $28 million to resolve allegations that it solicited and received kickbacks from Abbott Laboratories in exc...[ Price : $8.95]
Federal Register Notice: FDA makes available a guidance on ANDA Submissions Prior Approval Supplements Under GDUFA.[ Price : $8.95]
Federal Register Notice: FDA and Johns Hopkins University Center of Excellence in Regulatory Science and Innovation announce a 11/...[ 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...