“Me too” drugs do not get much benefit of the doubt from FDA when safety concerns surface after approval, but the agency will go to great lengths to keep drugs considered to be medical advances available for at least some patients.
Medical Advances Get More Chances When Safety Issues Arise
Withdrawn “me too” NMEs were removed from the market sooner after post-marketing safety signals than first-in-class or advance-in-class NMEs, showing the importance of available alternative therapy (or the lack thereof) in post-marketing risk management decisions.
More from Drug Safety
More from Pink Sheet
• By
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
• By
England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
• By
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.