This would include reviewing your websites, product labels, catalogs, brochures, flyers, package inserts, audio and video, e-commerce and social media accounts you operate (e.g., Amazon, eBay, Facebook and Twitter accounts), as well as any other promotional materials, and removing product claims, consumer testimonials, metatags, and anything else that states or implies that your products are useful in treating, curing, mitigating, diagnosing, or preventing diseases.įor more information on the kinds of claims that establish that a product is intended for use as a drug, please see 21 CFR 101.93(f)-(g) and. We advise you to review all materials through which you communicate to consumers the intended uses of your products, and to either submit a new drug application (NDA) for products intended for use in treating, curing, mitigating, diagnosing, or preventing a disease or, alternatively, remove all statements indicating that your products are intended for such uses. Your drug products do not have FDA-approved applications as required by 21 U.S.C. Before a new drug may be marketed or otherwise introduced into interstate commerce, it must be approved by FDA on the basis of scientific data demonstrating that the drug is safe and effective under the conditions of use in its labeling. § 321(p) because they are not generally recognized as safe and effective for the uses recommended or suggested in their labeling. These products are also new drugs as defined under 21 U.S.C. As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act. For example, your websites recommend or suggest the use of Combination Herpes Treatment, L-Lysine, Tribulus, Astragalus, Rhodiola, and Amino Acid Formula (or “Unique Amino Formula”) to treat or cure herpes simplex virus and heart disease. § 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of disease. Various claims and statements made on your websites and/or in other labeling establish that these products are drugs as defined in 21 U.S.C. Food and Drug Administration (FDA) reviewed your websites at and in November 2017 and has found that you take orders there for Combination Herpes Treatment, L-Lysine, Tribulus, Astragalus, Rhodiola, and Amino Acid Formula (or “Unique Amino Formula”). This letter is to advise you that the U.S. Andrews is affiliated with Stetson University.Synergy Health Combination Herpes Treatment, L-Lysine, Tribulus, Astragalus, Rhodiola, Amino Acid Formula (or “Unique Amino Formula”) With a new chief executive officer, Trulance sales beginning to accelerate, and other products moving through the FDA approval process, Synergy needed to decide whether to stay the course and become a full-fledged pharmaceutical company or seek a partner and stick to its research and development competency. In September 2018, the company was heavily indebted and the stock was priced below US$2 many wondered if Synergy had been right to go it alone or if it should continue that strategy for developing the lucrative North American market. The company had not partnered with a larger pharmaceutical company during the regulatory review process, which was typical for smaller drug development companies, and as a result, it retained 100 per cent of the sales revenue but had virtually no in-house sales or marketing capability. Synergy now needed to scale up from a research-and-development shop to a sales-and-marketing powerhouse. (Synergy) received marketing approval from the US Federal Drug Administration (FDA) for its first drug, Trulance, which targeted a large market that had only two other approved competitors. After more than a decade of development, US-based Synergy Pharmaceuticals Inc.
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