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…effective June 17, 2010, and was to be fully implemented by June 17, 2011. Thus, at the time of the audit, the industry had barely two years of experience with…
…the Dot Com Disclosures since May 2011. According to Mary Engle (Associate Director, FTC Division of Advertising Practices), the FTC is accepting written comments on the issue through July 11,…
Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures. The FTC released the original guide 13 years ago, when mobile phones…
…in Arkansas La. Gas Co. v. Hall, 453 U.S. 571 (1981), and Buckman Co. v. Plaintiffs’ Legal Comm.,531 U.S. 341 (2001), the Supremacy Clause forecloses state-law claims that depend on…
…formulation, dosage form, strength, method of manufacture, route of administration, indications or intended patient population. If a company claims that its product is grandfathered, FDA considers it the firm’s burden…
…active ingredients that are marketed, albeit at different dosages or indications, both as a prescription and OTC product. For instance, aspirin, while marketed OTC, also has professional labeling for the…
…October 2006 (Docket No. FDA-2006-P-0448) concerning Azithromycin for Oral Suspension, thereby potentially bringing FDC Act § 505(q)(1)(G) into play, that petition, which FDA denied in August 2011, was specific to…
…recommended that physicians test their patients for “suboptimal” plasma levels through Avantix Laboratories. To add insult to injury, DDMAC determined that the Avantix website, www.bloodleveltesting.com, was registered to Novartis, its…
…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…
…for the evaluation of device performance. There are academic studies, journal articles, disease‑focused societies, symposia, conferences, case studies, clinical guidelines, talks by key opinion leaders, and a host of other…
…Tracker.) As we previously reported, [http://www.fdalawblog.net/2018/08/it-feels-like-the-first-time-fdas-first-competitive-generic-therapy-approval/] FDA designated Apotex, Inc.’s (“Apotex’s”) Potassium Chloride Oral Solution USP, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%), drug products as “Competitive Generic…
…ages of 1 and 4 years, is reportedly the most common malignancy diagnosed in children, representing about 23% of childhood cancers. Nevertheless, in 2012, when Nova requested orphan drug designation,…
…(here, , and ). Takeda and Elliott, in their Opening Briefs (here and here) filed in the D.C. Circuit, pitched their appeals as presenting issues that, if not resolved with…
…Tablets, 0.6 mg, and Elliott Associates, L.P., Elliott International, L.P., and Knollwood Investments, L.P. (collectively “Elliott”), entities with investment interests in COLCRYS, in a dispute stemming from FDA’s September 26,…
…and more is sure to come as the tea leaves from the argument are read, and a decision is ultimately issued. We will continue to follow the developments, but for…