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The FDA released two final guidances yesterday outlining the agency’s approach to drug-drug interaction (DDI) studies for DDIs mediated by cytochrome P450 (CYP) enzymes and transporters. Read More
In a final guidance, the FDA outlined the new structure of the user fee program under the Biosimilar User Fee Act of 2017 (BSUFA II) which eliminated certain fees and extended the agency’s authority to collect fees through fiscal 2022. Read More
The FDA issued Australian contract OTC drugmaker Tismor Health and Wellness a warning letter for serious GMP violations and data integrity lapses. Read More
The Drug Enforcement Administration (DEA) should expedite two new regulations to make opioid addiction treatments more readily available, three Democratic lawmakers said, noting that the agency was supposed to have issued such rules by October 2019. Read More
A routine document released by the FDA on Wednesday raised new questions about the agency’s rejection — and subsequent approval — of Sarepta’s Duchenne muscular dystrophy (DMD) treatment Vyondys 53. Read More
The third phase of restructuring at the Office of New Drugs is underway, setting up an Office of Nonprescription Drugs and an Office of Specialty Medicine. Read More
A congressional committee may be planning to throw its weight behind “complex generics” as part of a push to increase generic options and lower drug costs. Read More