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…safety and will result in a significant reduction in the cost of covered products to the American consumer (21 U.S.C. § 384). AHCA prepared the Concept Paper to set forth…
By Carrie S. Martin – FDA just released the Warning Letter it issued to Novartis Pharmaceuticals Corporation (“Novartis”) in April regarding two purportedly unbranded websites, www.gistalliance.com and www.cmlalliance.com (the “alliance…
…Revised 21 C.F.R. § 312.32(c)(3). For BA/BE studies, each report must be submitted on FDA Form 3500A or in an electronic format that FDA can process. Revised 21 C.F.R.§ 320.31(d)(3)….
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…in the Act, please contact: Michelle L. Butler, mbutler@hpm.com, 202-737-7551 Alan M. Kirschenbaum, akirschenbaum@hpm.com, 202-737-4283 Jeffrey N. Wasserstein, jwasserstein@hpm.com, 202-737-9627 David C, Gibbons, dgibbons@hpm.com, 202-737-4286 Serra J. Schlanger, sschlanger@hpm.com, 202-737-4593…
…drugs in 21 C.F.R. § 310.545. The compliance (or effective) date is Dec. 20, 2018. On or after that date, any OTC health care antiseptic drug product that contains any…
…guidance, a “remote regulatory assessment.” Of the 11 warning letters, 6 of the warning letters identified cGMP issues in the records reviewed (see, e.g., Warning Letter to Suhan Aerosol). As…
…other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids . . ….
…cosmetic contact lenses without a prescription was illegal. Apparently, not everyone got the message. No listing on the docket sheet as to how the companies will respond to the charges….
…approval was suspended under this paragraph. The notice will satisfy the requirement of § 314.162(b). . . . (6) If the agency determines in its final decision that the listed…
…[a] drug [or] device . . . if such act is done while such article is held for sale . . . after shipment in interstate commerce and results in such article being adulterated.” 21 U.S.C….
…materials, and goods at wholesale price. Although led to believe otherwise, most of the distributors/members made little to no money through sale of product. FTC claimed that the compensation…
…state laws from discriminating against interstate commerce, or favoring in-state commerce over out-of-state commerce. New York moved to dismiss each case on jurisdictional grounds under the Tax Injunction Act (TIA),…
…that other state allows the sale of raw un-pasteurized milk and or dairy products. Last December, OPDC sued FDA to compel a response to the citizen petition. On February 26,…
…the customer can place an order” (emphasis added) includes an establishment’s homepage (e.g., www.CafeEtan.com), or only the specific webpage from which customers can place an order (e.g., www.CafeEtan.com/order). It is also…