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Health Canada has proposed fee hikes for reviewing applications for approval of new drugs, for oversight of drug manufacturing facilities, for postmarket monitoring of drug sales and for other regulatory activity. Read More
Finger-pointing abounded Tuesday in a Senate hearing on prescription drugs prices, where branded and generic drug industry representatives testified alongside pharmacist, wholesale distributor and benefit manager groups. Read More
The White House’s Office of Management and Budget (OMB) proposes to delay for one year, until January 2019, the effective date of a revision to the sweeping Common Rule that governs federal policy on the use of human subjects in clinical trials. Read More
An FDA advisory committee voted 10 to 1 that a muscular dystrophy drug candidate does not have enough supporting data to be considered effective, noting problems with interpreting data from clinical trials. Read More
The FDA sent Intellipharmaceutics a complete response letter for Rexista — an extended-release oxycodone tablet rejected in July by an FDA advisory committee — calling for additional clinical studies of the drug’s abuse-deterrent properties. Read More
An FDA advisory committee deadlocked 6 to 6 on whether the benefits of a Pfizer drug treatment for recurrent renal cell carcinoma outweighed the risks. FDA representatives noted the drug was associated with more toxicities than the placebo in clinical trials. Read More
The FDA is committed to using real-world evidence in drug approvals and post-market evaluations, and forthcoming guidance will describe RWE and its potential for satisfying FDA’s pre- and post-market requirements. Read More