FDA will post advisory committee briefing materials on its Web site at least two business days in advance of meetings, doubling the current lead time in an effort to enhance transparency, according to a Feb. 28 draft guidance
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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 remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.
