ANDA Applications Could Hit New Record in Fiscal 2017
Fiscal 2017 could be a record-setting year for ANDA applications if trends continue. Source: Drug Industry Daily
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…
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…
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
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