Researchers from FDA and other entities recommend ways to improve the collection and analysis of overall survival (OS) data in cancer drug trials.
Three stakeholders recommend changes to an FDA draft guidance on human- and animal-derived materials in cell and gene therapeutic materials.
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.
Aquestive asks FDA not to approve any nasal sprays that do not submit food effect studies as part of their application.
FDA warns Amazon and Walmart they are introducing unapproved chemical peel products into interstate commerce.
Citing a lack of legal authority, FDA denies a Public Citizen 2019 petition asking it to join with the Drug Enforcement Administration to reschedule t...
