Supplement manufacturer will clarify labeling after confusion regarding potency of Now Double Strength Glucosamine & Chondroitin and Now Chondroitin Sulfate caused Consumer Reports to incorrectly list supplements as subpotent in its January issue, company says (1"The Tan Sheet" Dec. 17, 2001, p. 18). NowFoods President/CEO Elwood Richard sent Dec. 14 letter to CR detailing the error, and in early December CR's analytical laboratory director confirmed firm's assertion, NowFoods says. Company's Web site currently displays Jan. 10 letter to customers explaining error's resolution...
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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.’
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.
