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According to the complaint, the labels understate the percentage of users the symptoms effect at only 1 or 2 percent, when in fact it is closer to 50 percent. Read More
The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft, which were due last week. Read More
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