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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
FDA investigators found API production records all over the floor, desks and cabinets of the quality unit in Yibin Lihao Bio-technical’s Sichuan, China facility. Read More
Post-inspection Official Action Indicated (OAI) classifications by CDER and CBER have dropped sharply in recent years, according to the latest data from the FDA’s Inspection Classification Database. Read More
The Government Accountability Office (GAO) laid out policy options for dealing with the challenges of machine learning in drug development in a report released yesterday — noting that uncertainty about potential regulation of machine learning is hindering its adoption. Read More