Sunscreens containing an SPF over 30 will be required to use one collective term, "SPF 30 plus" or "SPF 30+" on labeling under FDA's final sunscreen monograph published in the Federal Register May 21. Due to the projected considerable economic burden on sunscreen manufacturers to comply with the regulation, FDA is extending the proposed 12-month compliance deadline to 24 months (for other provisions of the reg, see chart, p. 6).
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
