PALO ALTO, Calif., May 25, 2021 /PRNewswire/ -- I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-winning technology "induced pluripotent stem cells (iPSCs)" ...
FDA's Brian Hasselbalch provides an overview of trends found in FDA quality inspections over the past year. It is essential that pharmaceutical manufacturers follow current good manufacturing ...
Wockhardt, a Rs. 4, 450 crore plus pharma major, received another blow as the US FDA issued fresh warning letter for significant violations of current good manufacturing practice (cGMP) regulations ...
Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This ...
SEATTLE, March 05, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment ...
In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information ...
This is regarding an inspection of your pharmaceutical manufacturing facility, Batamandi (Unit II), in Paonta Sahib, India by Investigator Jose R. Hernandez and Chemist Susanna E. Ford, during the ...
As a background summary, CGMP represents the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMP guidelines provide for systems that give ...
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