FDA Approval Via "Living License" Gaining Backers, But Major Players Not Among Them
Support appears to be growing for FDA to adjust its approval system, including moving away from what has been called an “all-or-nothing” process to include a limited-launch approval mechanism.
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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.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.