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Allergan asks FDA to apply multiple restrictions to ANDAs citing its Restasis as the reference-listed drug.[ Price : $8.95]
With two months to go this fiscal year, CDERs Office of Generic Drugs moves toward eclipsing last years record approval (651 ANDAs...[ Price : $8.95]
FDA clears a Stimwave 510(k) for the StimQ Peripheral Nerve Stimulator System, a wireless, micro-technology neuromodulation device...[ Price : $8.95]
Mylan CEO Heather Bresch blames FDA reorganization for delays in approvals for two new generic drugs.[ Price : $8.95]
FDA accepts for priority review a Genentech supplemental NDA for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRA...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance on CMC Postapproval Manufacturing Changes for Specified Biological P...[ Price : $8.95]
FDA warns Canadas Cellex-C drug manufacturing firm about significant CGMP violations.[ Price : $8.95]
FDA warns the Philippines Skin Sciences Laboratory about CGMP violations in its production of misbranded unapproved new drugs.