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…the Michigan law, which compelled participation by the plaintiff telephone companies, denied them of their right to a “fair and reasonable rate of return.” Order at 22. As such, that…
By John A. Gilbert, Jr. & Larry K. Houck – A bipartisan group of thirteen congressional representatives penned a letter to Administrator Michele Leonhart last week requesting “clarification, guidance and…
…seeking “information on and examples of appropriate uses of the custom device exemption.” 77 Fed. Reg. 69,488, 69,488 (Nov. 19, 2012). In particular, FDA is seeking information related to instances…
…10. 21 CFR 870.5200 External cardiac compressor. 11. 21 CFR 870.5225 External counter-pulsating device. 12. 21 CFR 870.5310 Automated external defibrillator. 13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form)….
…heart disease, and diabetes to pay $70 million in consumer redress. The court’s order dated August 13, 2009 did not come until more than 6 years after the date of…
…interesting questions touched on in some recent court decisions. But before we get to those cases, some law . . . . The patent statute at 35 U.S.C. § 154(a)(2)…
…labeling are not reasonably certain to be followed in practice . . . .” FDA’s regulations prohibit the extralabel use of fluoroquinolones in food-producing animals (21 C.F.R. § 530.41(a)(10)), and,…
…during the COVID-19 Peacetime Emergency. The Executive Order allows the Commissioner of Health to permit a healthcare practitioner to certify a patient’s qualifying medical condition after a visit through videoconference,…
…any glatiramer acetate injection drug product . . . before the Agency has had an opportunity . . . to fully consider specific data and information in such an application.” …
…of the date customers completed them. They also review CSOS transactions for completeness and accuracy. Investigators review the registrant’s Powers of Attorney to ensure that individuals ordering schedule I and…
…they “possess[] and rel[y] upon competent and reliable scientific evidence that substantiates” the claim. According to FTC, Hi-Tech continued to promote weight loss products without having the required substantiation. In…
…permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use. . . . Furthermore, in order to determine when the 60-day…
…Fed. Reg. 8432 (Jan. 25, 2017) Donald W. Lamoreaux, M.D., 82 Fed. Reg. 8434 (Jan. 25, 2017) Richard W. Walker, Jr., M.D., 82 Fed. Reg. 9223 (Feb. 3, 2017) Janet…
…Inc., (the Company) for falsely advertising its sunscreen product as “all natural” in violation of Sections 5 and 12 of the FTC Act. On December 12, 2016, the FTC issued…
…920 F.2d 984 (D.C. Cir. 1990) (here). If a drug product contains any previously approved active moiety (i.e., if it is not composed of all NCEs), then FDA historically denied…