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CDER released a revised Manual of Policies and Procedures on expedited reviews of prior approval supplements for new drug and biologics license applications that involve chemistry, manufacturing and controls changes. Read More
After experiencing a steep decline early in 2018, generic drug approvals by the FDA are climbing back towards last year’s highs according to the latest FDA report. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six medicines, including an orphan drug, for approval at its March meeting, in addition to three recommendations for extensions of indications. Read More
The FDA denied Insys Therapeutics’ petition asking the agency to reject abbreviated new drug applications for generics of Syndros (dronabinol) oral solution that rely on a waiver instead of establishing in vivo bioequivalence. Read More