We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued a draft and separate final guidance dealing with when the agency would exercise enforcement discretion for certain violations covering repackaging products. The draft addresses biologics, while the final guidance deals with drugs. Read More
Spanish drugmaker Grifols is accused of defrauding the government of millions of dollars for promoting the use of its antithrombin drug, Thrombate III, in unapproved indications. Read More
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites. Read More
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall batches of its drug products due to significant GMP deficiencies. Read More
Taking into account industry criticism, the FDA has loosened the data requirements that drugmakers will have to meet to determine the admissibility of imports entering the U.S. Read More
FDA investigators have cleared Akorn’s facility in Illinois for production, following a re-inspection that confirmed the company corrected several GMP deficiencies. Read More
The FDA has rejected Advanced Accelerator Applications’ candidate for the treatment neuroendocrine tumors in adults, requesting that the company submit new analyses and correct manufacturing deficiencies. Read More