Basically every doctor prescribing any opioid is now covered by the REMS, but training remains voluntary.
The number of opioids encapsulated by the US FDA's risk evaluation and mitigation strategy (REMS) has now increased nearly six-fold, as the agency officially extended it to immediate-release (IR) opioids intended for use in an outpatient setting.
When first created in 2012, the REMS only applied to 62 extended-release (ER) and long-acting (LA) products, but the extension to IR opioids announced Sept. 18 has now bloated that...
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.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
