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.
You may also be interested in...
REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'
Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.
REMS Abuses: Congressional Panel’s Focus Turns To Federal Trade Commission
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.
US FDA Open To Cell Therapy ‘Assessment Aid’ That Could Speed Development Of Next-Gen Cancer Drugs
A framework for sponsors and the FDA to discuss ways to extrapolate existing data to support a new cell therapy could cut the time to approval.