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Disease-focused guidance and a new knowledge management platform are among the key initiatives in the FDA’s fiscal 2019 budget request of $5.8 billion, Commissioner Scott Gottlieb told the House Appropriations Committee on Tuesday. Read More
The committee has been investigating the activities of drug wholesalers who are legally required to report suspicious orders of opioids to the Drug Enforcement Agency. Read More
Judge Dana Christensen of the U.S. District Court for the District of Montana sentenced the company’s founder, Kris Thorkelson to six months' house arrest, five years' probation and a $250,000 fine. Read More
Moves to increase clinical trial data transparency gathered momentum this week with the release by Vivli of the beta version of its clinical trial data-sharing platform to the public prior its full rollout on July 19. Read More
The FDA rescinded a refuse-to-file letter it issued to Alkermes in March for the company’s experimental treatment for depressive disorder, the company announced Monday. Read More
The FDA announced a new pilot program in which drug sponsors can meet with agency officials to discuss strategies for model-informed drug development (MIDD) to make their clinical trials more efficient and increase the chances of regulatory approval. Read More
The emergency petition requests the FDA’s withdrawal order be stayed until 30 days after the D.C. Circuit makes a decision regarding judicial review of the agency’s order. Read More