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…benefits provided by drug and device manufacturers. Advisory Opinion 15-11, posted today, involves a manufacturer’s short-term free-drug program. The other, Advisory Opinion 15‑07, which was posted in June, concerned a…
…25, 2016, in a criminal case, United States v. Vascular Solutions, Inc., on which we previously posted here and here, a jury acquitted Vascular Solutions, Inc. (“VSI”) and its CEO,…
…FDA-required labeling in accordance with FDA’s stated 3-factor analysis. Clearly, OPDP thinks differently. As part of the Warning Letter, OPDP states, “To date, no drug has been shown to improve…
…Fixed-Dose Combination Drugs (“FDCs”) containing an NCE and a previously-approved drug – specifically STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Tablets (Docket No. FDA-2013-P-0058); PREPOPIK (sodium picosulfate, magnesium oxide and…
…regarding these complex products, to avoid potentially unsafe substitution of biosimilars and reference products, and to combat widespread misconceptions among prescribers about biosimilars and their relationship to reference products,” writes…
…not compelled under the PHS Act.” For good measure, FDA asserts that the Amgen petition “implicitly acknowledges” that this is a matter of FDA discretion. In support of its conclusion,…
…products could treat, prevent, or reduce heart disease, prostate cancer, and erectile dysfunction. According to the FTC, those claims were false and misleading because POM did not have valid and…
…November 4, 2014, three related entities – Elliott Associates, L.P., Elliott International, L.P., and Knollwood Investments, L.P. (collectively “Elliott”) – with investment interests in COLCRYS filed a separate Complaint against…
…(briefs available here, here, here, here, here, and here) and holding Oral Argument in September 2014, the Fourth Circuit issued its decsion on December 16, 2014. Analyzing this issues…
…Slaughter; Len Lichtenfeld, Deputy Chief Medical Officer for the American Cancer Society (Moderator); Elizabeth Mansfield, Deputy Director for Personalized Medicine, Office of In Vitro Diagnostics, FDA; Judith Yost, Director, Division…
…facility while it is inspecting a different facility. When inspecting a drug facility, section 704 applies to, among other things, “all things therein (including records, files, papers, processes, controls, and…
…as part of the investigation and the soil bug, Bacillus thurengiensis, was recovered. Yet, FDA investigators claimed that no CAPAs had been initiated “…to clean, disinfect, sanitize, or sterilize the…
…Complaint, Ferring alleges that FDA’s actions violate the Administrative Procedure Act, the FDC Act, and the Agency’s regulations. Specifically: First, Ferring contends that the FDA’s prior interpretation, under which PREPOPIK…
…statement, we knew that denials of the STRIBILD and PREPOPIK Petitions for Reconsideration, as well as a denial of the DUAVEE Citizen Petition, would be coming soon. Indeed, just a…
…the AD Opioids Guidance, which describes the categories of AD products (e.g., physical/chemical barriers, antagonist) and types of abuse routes (e.g., intranasal, intravenous, oral). The Board believes that this scope…