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After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today. Read More
Sterile drugmakers seeking to comply with new EU GMP guidelines introduced in August 2023 should consider an in-depth gap assessment in their facilities — working through the guidelines line by line, two EU regulatory experts advised. Read More
The FDA smacked Samsung Biologics for using technology to support application submission testing that had inadequate data integrity controls, among other lapses, following an inspection of its Incheon, South Korea, facility conducted in August and September. Read More
Though it might seem counterintuitive given the complex regulations and procedures required of the drug and device development industries, the real key to better quality lies in simplifying operations, said Greg Williams, industry veteran and a quality assurance consultant based in Dallas-Ft. Worth. Read More
The FDA’s final guidance alerts drugmakers and compounders to the potential health hazard of alcohol (ethyl or ethanol) or isopropyl alcohol that is contaminated with methanol. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG.Read More
Under the terms of the agreement, the methods that will come out of this partnership will be made available to other domestic generics manufacturers. Read More
To stretch the available doses, the FDA issued an emergency authorization that allows for a one-fifth dose to be administered beneath the top layer of the skin. Read More