Although the issue of misuse of risk evaluation and mitigation strategies (REMS) and non-REMS restricted distribution systems to prevent generic competition from reaching the market has been touted in recent months as one needing a legislative solution, US FDA Commissioner Scott Gottlieb is eyeing on a more active role for the agency to play on the subject.
Gottlieb Talks Activist Role For FDA In Curbing REMS Abuse
US FDA commissioner says he would be happy to work with Congress on a legislative solution on the issue, but emphasized his priority is for the agency to develop a system itself to discourage REMS abuse.
More from Drug Safety
• By
The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
• By
The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
• By
Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.
• By
The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.
More from Pink Sheet
• By
The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
• By
Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.
• By
The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.