The REMS Ramp Up: FDA Using New Safety Tools More Frequently In Year Two
• By Michael McCaughan
FDA has invoked formal Risk Evaluation & Mitigation Strategy Authority almost as often the last five months as it did in the first full year of the program. Use of more intense REMS-those with communication plans and elements to assure safe use-is increasing even faster, and indications are this is the leading edge of a wave of new restrictive programs. REMS unquestionably delay approvals, FDA officials acknowledge-and yet, more drugs are coming out of FDA.
FDA is using its new Risk Evaluation & Mitigation Strategy
authorities much more frequently in the second year since the law
took effect.
The REMS provisions began in March 2008. By FDA's count, the
agency invoked the new authority 34 times during the ensuing 12
months.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
