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By Cassandra A. Soltis – For the first time ever, the Federal Trade Commission (“FTC”) took action against a consumer for misrepresenting in a testimonial the amount of money she…
…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…
…program antikickback statute (“AKS”, 42 USC 1320a-7b(b)), the OIG recognized that the program operates entirely outside of all Federal health care programs, meaning that patients obtain the product without using…
…such as roadside stands, farmers’ markets, Community Supported Agriculture (CSA) programs, and other direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online…
…falsely claimed that their cosmetic products are “all natural” or “100% natural,” even though their products contained synthetic ingredients. Allegedly the companies made the all and 100% natural claims in…
…industry, Godot finally made a cameo appearance as FDA issued a draft guidance titled, “Fulfilling Regulatory Requirements for Postmarketing Submission of Interactive Promotional Media for Prescription Human and Animal Drugs and…
…collected by DEA since 1971 can be an effective enforcement tool and in certain cases can assist manufacturers and distributors to identify potential outliers. We reported here that in November,…
…Orange Book – that is, all of the prior editions and supplements from the 1979 draft edition to the current 2020 BPCIA Transition edition and beyond – were available online…
Genetics and genomics are becoming crucial to clinical care. As the “precision medicine” revolution spreads, cancer treatment, rare disease diagnosis, and cardiac care increasingly utilize genomics. Unfortunately, law and policy…
…[and] manifestations of inborn errors of metabolism” but also experts in “small population trial design, translational science, pediatrics, epidemiology, or statistics and related specialties” (emphasis added). Note that FDA is…
…discovered during a routine 2018 FDA inspection (unrelated to compounded drugs), which had never been reported to the Agency. The adverse events allegedly included possible association with endometrial cancer, prostate…
…forum in which to plant their respective flags, and to draw attention to the issues they view as critically important. Potential benefits of cannabis and its derivatives? Check. Potential safety…
…supply this year are drugs used to treat childhood leukemia, breast cancer, and colon cancer, as well as anesthetics, and antibiotics. When a vital medicine is in short supply, doctors…
Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. In addition to the widely…
…commerce and used by consumers, and for which there is the greatest potential for consumers or environmental receptors to be exposed to the chemical in quantities that can result in…