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…Horton’s from Canada. On February 28, 2017, Senators Bernie Sanders, Cory Booker, and Bob Casey introduced S. 469, the “Affordable and Safe Prescription Drug Importation Act.” (A companion bill was…
…and Budget. August 31, 2016 vi. Publication of Final Monograph. September 15, 2016 b. Healthcare Antiseptic Products Monograph i. Publication of tentative final monograph. April 30, 2015 ii. Comment period for…
…OTC drug products, including antibacterial soaps. According to the NRDC, “[t]hese chemicals are suspected endocrine disruptors linked to reproductive and developmental harm in laboratory studies. . . . FDA needs…
…receives. Comments are due by November 26, 2007. With respect to implementation of a final rule, FDA commented that the Agency “understands the seasonal nature of the sunscreen industry and…
…to do so in light of the “significant/complex issues [raised by the petition] requiring extensive review and analysis by Agency officials.” Compl. ¶30. Public Citizen’s suit faces an uphill battle,…
…to switch PLAN B (and all emergency contraceptives like it) from prescription-only to OTC status without age or point-of-sale restrictions. FDA’s August 24, 2006 approval permitted Over-the-Counter (“OTC”) use of…
…of $12,000,000 for pharmacy compounding activities specified in the Drug Quality and Security Act (DQSA). The Committee urges FDA to complete inspections of compounding facilities that clearly fall within the…
…PLAN B One-Step (levonorgestrel) Tablets, 1.5 mg (“PBOS”), be made available Over-the-Counter (“OTC”) without age or point-of-sale restrictions (see our previous post here), we were wondering how FDA was going…
…the proposal.” 85 Fed. Reg. at 62,112. According to the Plaintiffs, Section 804 does not contemplate or permit this SIP-by-SIP determination. In addition, the Plaintiffs argue that there is no…
…on OTC promotion OTC Post Marketing Challenges: Addressing Adverse Events, Product Recalls, Inspection and Investigations Hyman, Phelps & McNamara, P.C. Director Deborah L. Livornese will be speaking at the event…
…any necessary changes to their business arrangements and come into compliance. OIG stated that the updated effective date should not impact the 2020 Part D bid submission process. (p. 76673)…
…in the repository. For each OTC monograph title (e.g., nighttime sleep aid drug products), the repository provides an OTC Monograph ID (e.g., M002) and an Order ID (e.g., OTC000001) and…
…FDA, should they somehow be unable to locate the company or, as is usually the case, prefer not to report to the company. The labeling changes FDA seeks would have…
…ingredients under consideration for inclusion in an OTC monograph. The 20-page proposal is intended to harmonize the rules for fixed-combination prescription and OTC drugs. For purposes of the proposed rule,…
…proofing. The threat has become real. On November, 15, 2016, the FTC issued an enforcement policy for homeopathic products. Essentially, the FTC has decided to hold homeopathic over-the-counter (OTC) products…