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…a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.” To that end,…
…RCTs are impractical, impossible, unethical, too costly, etc., the FTC asserts that it does not matter whether a claim is for a food, a dietary supplement, a cosmetic or a…
…no later than Tuesday, April 17, 2012, at 5:00 PM. A hearing on ViroPharma’s Motion for a Temporary Restraining Order is set for Thursday, April 19, 2012, at 2:30 PM….
…which prohibit the marketing of a new drug without an effective approval, by approving, authorizing, inviting, encouraging, and permitting “the introduction, and delivery for introduction, into interstate commerce of unapproved…
…practice.” 21 U.S.C. § 353(f)(1). Generally, an “order” is “lawful” if it is a prescription or, if an oral order, it is both promptly reduced to writing and filed by…
…permitted by the doctrine of res judicata. See Jose G. Zavaleta, M.D.; Decision and Order, 78 Fed. Reg. 27,431 (May 10, 2013). Second, the decision states that the government argued…
By Allyson B. Mullen – As we previously posted, in June 2011, ReGen Biologics, Inc. (“ReGen”), which was subsequently acquired by Ivy Sports Medicine, LLC (“Ivy”), sued FDA based upon…
…of topics, including: The organization, jurisdiction, functions, and operations of FDA The essentials of the approval process for drugs and biologics, including: INDs, NDAs, BLAs, OTC Approval, the PMA process…
…a public list of off-patent and off-exclusivity NDA products without ANDA competition. Effective June 27, 2017, MAPP 5240.3 Rev. 3, Review Order of Original ANDAs, Amendments, and Supplements, updates FDA’s…
…Nutrition, Inc., (No. 92-3087), 2010 WL 2811203 (F.T.C. July 14, 2010); Stipulated Final J. and Order for Permanent Inj. And Other Equitable Relief, FTC v. Iovate Health Sciences USA, Inc.,…
…exclusivity], Amgen shall respond to the reconsideration decision by July 3, 2017; and FDA shall issue a decision on dispute resolution by August 2, 2017,” says the Order. If FDA,…
…means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5. FDA purportedly approved Augment Bone Graft on September 1, 2015 under Premarket…
…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…
…Order as a whole. Thus, regardless of what happens at the Supreme Court, POM will be subject to at least a major part of the FTC’s Order. However, POM asserts…