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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The FDA rescinded a refuse-to-file letter it issued to Alkermes in March for the company’s experimental treatment for depressive disorder, the company announced Monday.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
“Maryland cannot, even in an effort to protect its consumers from skyrocketing prescription drug costs, impose its preferences in this manner,” the appeals court said. Read More
Lannett filed an emergency petition with the FDA requesting postponement of the agency’s withdrawal order for its ANDA for Glycolax pending a court ruling. Read More
Numerous federal agencies have strategies to address illicit opioid use but almost all lack concrete goals and outcome-oriented performance measures, the Government Accountability Office said in a new report. Read More
The U.S. Court of Appeals for the Fourth Circuit struck down Maryland’s generic drug pricing law Friday, ruling that the law is unconstitutional because it regulates trade beyond the state’s borders. Read More
The FDA finalized guidance on its special protocol assessment (SPA) program that offers sponsors an advanced declaration from the agency that their trial designs, clinical endpoints, and statistical analyses are acceptable. Read More