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S4 De Novo Authorization for esolution

[ Price : $8.95]

FDA grants S4 Medical a de novo authorization to market its esolution esophageal deviation device.

Novartis Recalls Sandimmune Lot

[ Price : $8.95]

Novartis recalls one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation obs...

FDA Updates Alert on Halyard N95 Masks

[ Price : $8.95]

FDA provides further clarification about a safety alert issued earlier this year that recommended against the use of certain surgi...

Endogenous Cushings Syndrome Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatmen...

Guide on ISO 10993-1 Biological Evaluations

[ Price : $8.95]

Federal Register notice: FDA posts a final guidance entitled Use of International Standard ISO 109931, Biological Evaluation of Me...

Combo Product Human Factors Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Application of Human Factors Engineering (HFE) Principles f...

Senators Reintroduce Opioid Studies Bill

[ Price : $8.95]

U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) reintroduce their bipartisan FDA Review of Efficacy EERW Double-Blinds (FRE...

House Committee Hearing on Drug Shortages

[ Price : $8.95]

The House Energy and Commerce Committee announces a 9/14 legislative hearing to discuss legislative proposals on preventing generi...

IRB Review of Expanded Access Request Guide

[ Price : $8.95]

FDA posts a guidance entitled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Invest...

Subcutaneous Tecentrig Delayed Due to CMC Info

[ Price : $8.95]

FDA requests updated chemistry, manufacturing and controls information on Genentechs subcutaneous formulation of lung cancer drug ...