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Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 11/6 to discuss a guidance on virus...[ Price : $8.95]
Federal Register Final rule: FDA amends the medical device regulations to correct minor errors.[ Price : $8.95]
A new CDER policy document outlines procedures for informing NDA/BLA applicants about planned review timelines, including goal dat...[ Price : $8.95]
Alkermes files an NDA for aripiprazole lauroxil, a once-monthly, long-acting injectable atypical antipsychotic for treating schizo...[ Price : $8.95]
FDA reinspects Alexion Pharmaceuticals active pharmaceutical ingredient manufacturing facility in Smithfield, RI and documented th...[ Price : $8.95]
FDA clears a CorMatrix Cardiovascular 510(k) for the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic d...[ Price : $8.95]
A federal court grants FDA an injunction against dietary supplement maker BioAnue Laboratories (Rochelle, GA) and its owners, Glor...[ Price : $8.95]
Federal Register Notice: FDA determines that Sular (nisoldipine) ER tablets were not withdrawn for reasons of safety or effectiven...