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…online ads. Under the consent orders, the companies may not make such representation unless they have evidence to support the claim. They must have competent and reliable evidence to substantiate…
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…and himself, Mr. Sasinowski offered four recommendations: Proposal #1: FDA should consider the appropriateness of the Accelerated Approval process for every new therapy. Proposal #2: FDA and sponsors should use intermediate clinical…
…also reflected in FDA’s online database: Recognized Consensus Standards. The Draft Guidance explains that there are two “primary situations” where FDA may decide to withdraw recognition of a standard: (1)…
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…which sells green tea at www.teaforhealth.com, submitted its health claim petition to FDA on January 27, 2004. The company claimed that its green tea QHC was based upon two separate…
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