US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.
The US Food and Drug Administration is releasing information in clinical study reports that could help hackers identify patients, some groups said in formal comments about the idea.
Former Commissioner Scott Gottlieb spearheaded releasing clinical study reports (CSRs), which are scientific documents containing detailed summaries of clinical trial methods and results, as part of the action packages published...
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.
