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…Diversion Control Division secure network application. Of note, one commenter requested that the reexport provisions should apply to EEA member countries as of November 25, 2015, noting that the United…
…to commit adulteration under the Federal Food, Drug, and Cosmetic Act (“FDC Act”). Based on a complaint by Dr. Kaplan’s own medical assistants to the Nevada State Medical Board, FDA’s…
…on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as…
…that although the June 2006 CPG has “established an orderly approach for removing unapproved new drugs from the market,” such products “continue to come onto the market illegally,” because of,…
…3588 (S.D.N.Y. Mar. 8, 2016), Pacira Pharms., Inc. v. FDA, No. 15 Civ. 7055 (S.D.N.Y. Dec. 15, 2015), and United States v. Vascular Sols., Inc., No. 5:14-CR-00926 (W.D. Tex. Feb…
…California Business and Professions Code §§ 17200 and 17500, and California unfair competition and misappropriation common law in that they “unlawfully and unfairly advertised, marketed, promoted, distributed, and/or sold in…
…open to the public; (2) price concessions and direct sales to hospitals, clinics, and physicians, except for inhalation, infusion, or injectable drugs, or except as determined by CMS; and (3)…
…(2) offers some pro-competitive benefit.” The K-Dur Petitions have already drawn significant attention. Amicus briefs have been filed by PhRMA, GPhA, the Washington Legal Foundation, Bayer Corporation, and the New…
…are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bearsprimary responsibility for drug labeling. It is a central premise of the Food, Drug, and Cosmetic Act…
…Letters to Cody and Lannett (among other companies) to stop manufacturing certain unapproved narcotic drugs, including morphine sulfate oral solutions. At that time, FDA concluded that marketed unapproved morphine sulfate…
…found FDA’s August 18, 2014 Letter Decision permitting the approval of ANDAs for generic PRECEDEX not arbitrary, capricious, or otherwise not in accordance with law, but rather, a decision based…
…what many nutrition experts and health advocates, including Mrs. Obama, have been suggesting: Americans should shift their diets to more plant-based foods, such as legumes, seeds, nuts, whole grains, vegetables and…
…This statutory provision provides that: (a) Whoever, without the consent of the patentee, marks upon, or affixes to, or uses in advertising in connection with anything made, used, offered for…
…the generic applicant’s proposed RLD was based in the context of ANDA No. 75-250 for Prednisolone Sodium Phosphate Oral Solution. In that case, FDA approved WE Pharmaceuticals, Inc.’s (“WE’s”) ANDA…
…CPSIA to examine and assess, in consultation with consumer groups, juvenile product manufacturers, and independent child product engineers and experts, the effectiveness of the ASTM toy safety standard, ASTM-F963-07. Accordingly,…