Health Center For Better Living's advertising for its Metabolene weight loss formula was referred to the Federal Trade Commission by the Electronic Retailing Self-Regulation Program after the Naples, Fla.-based firm failed to respond to an inquiry, the Council of Better Business Bureau's arm says Aug. 29. ERSP reviewed HCBL's ad claims for Metabolene, including "effortlessly melt away 30 lbs. in 30 days," after receiving an anonymous complaint. The CBBB group also asked the firm to substantiate consumer claims included in its ads that are "in contravention of the criteria" in FTC's "Red Flag - Bogus Weight Loss Claims" guide. After firms fail to comply with recommendations from advertising reviews or respond to inquires, the self-regulatory arms of CBBB refer them to the FTC, which give the cases high priority in its consumer protection enforcement (1"The Tan Sheet" June 4, 2007, p. 11)...
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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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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.