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…cares about is like “location,” “location,” “location” in the real estate purchase context. It’s about “substantial evidence,” “substantial evidence,” “substantial evidence”. So whether we like it or not, or whether…
Every so often something comes across our desk that is so comical that we feel compelled to share it with others in the food and drug community who will also…
…notice: [Boehringer] claims December 15, 2009, as the date the new drug application (NDA) for PRADAXA (NDA 22–512) was initially submitted. However, FDA records indicate that NDA 22–512, received December…
…despite the agency’s strong statement about CBD, FDA has acted, primarily through Warning Letters (WLs), only when the claims for CBD are egregious. Last week, it shifted focus to CBD…
…of 768 comments submitted by patients, patient groups, advocacy groups, and professional societies, voted in favor of rescheduling. After review of scientific and medical evidence, and other considerations mandated by…
…2021, announcing the availability of the first group of deemed final administrative orders. In that notice, FDA also announced the establishment of a web portal, OTC Monographs@FDA, which provides access…
Welcome to the latest edition of HP&M’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Food & Beverage…
…Medications Act of 2017, 85 Fed. Reg. 62,634 (Oct. 5, 2020). Electronic comments on the proposed rulemaking must be submitted, and written comments postmarked, on or before December 4, 2020….
…for a material time under such conditions.” See Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 631 (1973); Premo Pharmaceutical Labs., Inc. v. United States, 629 F.2d 795,…
…to encourage value based arrangements in Medicaid New regulations to implement the alternative rebate for line extensions, including definitions of “new formulation” and “oral dosage form” A new, difficult hurdle…
Welcome to the latest edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our…
…Act (carve-outs)? Obviously, patent and FDA cases overlap often: innovation is critical to the drug industry and patents are critical to innovation, thus ANDA litigation, 30-month stays, etc. But, effectively,…
…a device from being marketed at all, as compared to a ban on particular uses of a device that could continue to be marketed. The court asked during oral argument,…
…be shown by such persons’ expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be…
…federal law.” Statement from President Biden on Marijuana Reform, White House (Oct. 6, 2022). Media outlets report, and HHS and Drug Enforcement Administration (“DEA”) officials confirm, that HHS has recommended…