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…
The FDA hit Optikem with a Form 483 after the agency’s investigator observed unsanitary conditions and problems with records in an inspection of the firm’s Denver facility. Source: Drug Industry…
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…
The FDA rescinded a refuse-to-file letter it issued to Alkermes in March for the company’s experimental treatment for depressive disorder, the company announced Monday. Source: Drug Industry Daily
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…
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. Source: Drug Industry Daily
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. Source:…
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…
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…
A whistleblower lawsuit accuses Mallinckrodt of systemically concealing concerns about the composition of its drug Acthar, indicated for treatment of infantile spasms. Source: Drug Industry Daily