Many of our clients and readers have NDAs, ANDAs, and supplements that are still pending approval due to a “complex regulatory issue” where the FDA has missed its goal date; in some cases, this missed date was many months ago. There can be several reasons for this type of delay but, as we have blogged […]
Today, in the Federal Register pre-publication notice (here), “the Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran (2-MTHF), cyclopentyl methyl ether (CPME), and tert-butyl alcohol (TBA).” The recommendations are based on the testing parameters established for developing permitted […]
Remember the days when the biggest concern that both consumers and the pharmaceutical industry had was about potential contamination of medications by nitrosamines? Just a few weeks ago, rumors were flying around fast and furiously among patient groups on social media, firms were issuing recalls of numerous medications, and regulators were involved in issuing policies […]
