The Office of Pharmaceutical Quality 2017 annual report outlines challenges and key quality initiatives addressed last year.
The Justice Department says it will file a Statement of Interest is lawsuits seeking damages from opioid manufacturers and distributors.
FDA warns Indias Alchymars ICM about deviations from current good manufacturing practice for active pharmaceutical ingredients.
Federal Register notice: FDA classifies Lynch syndrome test systems into Class 2 (special controls).
Federal Register notice: FDA corrects a 6/21/2017 Federal Register notice that incorrectly announced the withdrawal of a Baxter Healthcare NDA for Cli...
Federal Register notice: FDA announces a 5/9 public workshop on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Desig...
FDA warns Chinas Shanghai Weierya about CGMP regulation violations in its production of finished pharmaceuticals as a contract manufacturer.
Healthcare and legal researchers say the proposed Regulatory Accountability Act could have negative impacts on FDA and other agencies working to impro...