Archive for March 2017

Fiscal 2017 could be a record-setting year for ANDA applications if trends continue. Source: Drug Industry Daily

The FDA hit drugmaker Opto-Pharm with a warning letter, citing a lack of written procedures for preventing contamination of sterile drug products, as well as problems with validation, testing and labeling. Source: Drug Industry Daily

The FDA has accepted for review the first two novel, personalized cancer treatments — known as chimeric antigen receptor T-cell therapies, or CAR-T — using immune system cells drawn from the blood and reprogrammed to target cancer cells. Source: Drug Industry Daily

More than a dozen state pharmacy regulatory authorities told the GAO they have trouble communicating with the FDA on drug compounding issues. Source: Drug Industry Daily