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 proposed rule adding six bulk drug substances to the list of materials that can be used in compounding, while removing four substances. Read More
The FDA has faulted Sanofi and Celgene for running misleading TV advertisements for two of their drugs and ordered the companies to pull the commercials. 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 issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards. Read More
Japanese drugmaker Sekisui Medical Co., Ltd has received a warning letter after an inspection in June revealed significant data integrity issues. Read More
As part of its clinical trial data auditing initiative, the Chinese Food and Drug Administration verified data from an initial set of 55 clinical trials, focusing mainly on large, international drugmakers. Read More
The Morton Drug Company has received a warning letter as a result of FDA investigators witnessing unsanitary conditions at its Neenah, Wisconsin plant. Read More