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Three stakeholders recommend changes to an FDA draft guidance on human- and animal-derived materials in cell and gene therapeutic ...[ Price : $8.95]
FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage...[ Price : $8.95]
FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.[ Price : $8.95]
Two Axinn attorneys say FDA may be signaling more flexibility in considering novel Section viii carve-in statements in ANDAs.[ Price : $8.95]
The Justice Department says a resident of India has been indicted on federal charges of trafficking in fake cancer drugs sold in t...[ Price : $8.95]
The CDER Quantitative Medicine Center of Excellence posts four new resources.[ Price : $8.95]
Federal Register notice: FDA set biosimilar user fee rates for fiscal year 2025.[ Price : $8.95]
Federal Register notice: FDA posts the over-the-counter monograph order request fee rates for fiscal year 2025.