Congress’ Next Steps On REMS Abuses: Will Improving FDA-FTC Communication Help?
US FDA has seen little success in ending gaming of the patent process by brand name manufacturers. One problem: the agency’s referrals to FTC on anti-competitive cases appear go into a black box.
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Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.
During bipartisan, but one-sided, hearing about US FDA’s limited authority to ensure generic drug makers can access restricted distribution reference products for bioequivalence testing, one lawmaker wants to know what FTC is doing about the issue.
Accelerated Approvals Convert Much Faster If Confirmatory Trial Already Underway, FDA Cancer Data Shows
Oncology Center of Excellence’s ‘Project Confirm’ finds that if a confirmatory trial is ongoing at the time of accelerated approval, conversion to regular approval takes an average of three years versus 4.9 years if the trial starts after AA.