FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage forms.
FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.
Two Axinn attorneys say FDA may be signaling more flexibility in considering novel Section viii carve-in statements in ANDAs.
The Justice Department says a resident of India has been indicted on federal charges of trafficking in fake cancer drugs sold in the U.S.
The CDER Quantitative Medicine Center of Excellence posts four new resources.
Federal Register notice: FDA set biosimilar user fee rates for fiscal year 2025.
Federal Register notice: FDA posts the over-the-counter monograph order request fee rates for fiscal year 2025.
Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for Quantitative Testing for the Develop...
