FDA review of J&J's application to market its Confide home HIV sample collection kit appears to be progressing following a review by an FDA advisory panel in June ("The Tan Sheet" June 27, p. 19). Senior FDA executives are understood to have alerted the Clinton Administration that the agency sees no policy impediments to approving an OTC HIV test kit. Speaking at a Sept. 19 meeting sponsored by FDA and the Parenteral Drug Association, FDA Deputy Commissioner Mary Pendergast said that "as far as [FDA is] concerned, home-based collection kits for the HIV virus do not pose major regulatory difficulties if they are accurate and people can get counseling" from professionals
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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.’
Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.
Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.
One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.
