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FDA releases a CVM draft guidance entitled Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.[ Price : $8.95]
FDA clears an Apple 510(k) for its Apple Watch to be used as an over-the-counter device for assessing the risk of sleep apnea.[ Price : $8.95]
Boehringer Ingelheim plans an NDA for nerandomilast for treating idiopathic pulmonary fibrosis (IPF) after reporting that its Phas...[ Price : $8.95]
Fresenius Kabi recalls (Class 1) one lot of the Ivenix Large Volume Pump primary administration sets after documenting a manufactu...[ Price : $8.95]
FDA removes a partial clinical hold on Zentalis Pharmaceuticals azenosertib studies into the drugs use against solid tumors and tw...[ Price : $8.95]
Federal Register notice: FDA announces its support for Electronic Common Technical Document Version 4.0 (v4.0)-based electronic su...[ Price : $8.95]
FDA approves a subcutaneous injectable formulation of Genentechs Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for all t...[ Price : $8.95]
Federal Register notice: FDA corrects a notice that appeared in the 6/21 Federal Register announcing the approval withdrawal 20 AN...