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…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…
…80 Fed. Reg. 57756, 57757 (Sept. 25, 2015). This clause, however, appears nowhere in the preamble. Instead, there are citations to several court opinions that enumerate the types of information…
…Nathan a sales representative, had not pled fraud with particularity. Nathan filed a cert. petition alleging a split among the circuits. Specifically, Nathan claimed that the 4th, 6th, 8th, and…
…of our previous posts here, here, here, and here). In this case, the Court latched onto a comment from a discussion that occurred during oral argument regarding the fact that…
…over 69,000 public comments. The Commissioner gave no indication that the reconsideration would result in an extension of the compliance date beyond May 7, 2018. The forthcoming guidance, he said,…
…appears that bis-(p-hydroxyphenyl)-pyridyl-2-methane (BPHM, CAS: 603-41-8, UNII: R09078E41Y), the active moiety of sodium picosulfate (CAS: 10040-45-6, UNII: VW106606Y8), also seems to be the active moiety in bisacodyl [(4,4’-diacetoxydiphenyl(2-pyridyl)methane), CAS: 603-50-9,…