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…reinspection to cover reinspection-related costs, the responsible party for a domestic facility and an importer that does not comply with a recall order, and importers subject to a reinspection to…
…against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded…
…that the FTC attacked. The ALJ’s order would merely bar POM from making certain claims unless POM possesses competent and reliable scientific evidence to support the claim. As clarified in…
…could figure out how to comply. FDA originally set the PMTA deadline as August 8, 2022, but a district court in Maryland ordered FDA to shorten it. FDA complied with…
…“added sugars” followed by a parenthetical listing of the specific sugars added in descending order of predominance by weight. Earlier this month, Representative Rosa DeLauro (D-CT) sent FDA a similar…
…inoperable components immediately. Maintain documents and materials related to the security system and its components for future reference. Upon commencement of an inspection, the responsible employee should greet the investigators…
…of choice, however discussing the proposed comparator or even the use of a composite comparator with the FDA prior to initiating a clinical study is highly recommended. Sequencing can be…
…in Sections 513 and 712 of the Federal Food, Drug, and Cosmetic Act (the Act), respectively, in order to improve the premarket review process and foster innovation. These amendments would…
…Medifast Inc., for allegedly violating a 1992 FTC Order regarding weight loss claims. According to the complaint, filed in the United States District Court for the District of Columbia this…
…calls received for such substances in all of 2010. In addition, the U.S. Customs and Border Patrol has encountered at least 96 shipments of synthetic cathinones at one border; most…
…which Judge Hilton ordered the Patent and Trademark Office (“PTO”) to consider timely filed The Medicines Company’s (“MDCO’s”) PTE application for U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin) under a…
…a company’s employees could disclose otherwise privileged documents, or make statements on behalf of the company without the company’s knowledge. In In re Amgen, Inc., No. 10-MC-0249(SLT) (E.D.N.Y. Apr. 6,…
…will be of interest to the Hatch-Waxman community. The case, like so many Hatch-Waxman cases, is complicated. It involves an ANDA for a generic version of SOLARAZE (diclofenac sodium) Gel,…
…2003); 69 Fed. Reg. 17,034 (Apr. 1, 2004); 69 Fed. Reg. 58,050 (Sept. 29, 2004). In making its determination, DEA considered three of the eight statutory scheduling factors (as it…
…483. In response, FDA filed a complaint in August 2010 seeking to permanently enjoin Regenerative from using stem cells to treat patients without approval. The Court eventually issued an order…