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…education. In Lilly’s case, while this blogger does not believe that Component 1 should automatically be deemed Emgality promotion merely because it included Lilly’s name and discussed migraine, the context…
…state-authorized activities and did not violate the Cole memorandum? Undoubtedly, these application evaluation questions will form the basis of DEA’s proposed marijuana growing regulations. Lastly, the notice expressly confirms that…
…been marketed under a 505(b) New Drug Application (NDA). However, because they are not necessarily the same as any previously approved drugs, the title “ANDA” is a bit of a…
Over the past several years, FDA has faced criticism stemming from high-profile device issues related to materials, including the Essure permanently implanted birth control device and metal-on-metal hip implants. Given…
…is a bit short on conclusions but the cost continues to increase. This is not particularly surprising since last year CDC reported a continued increase in incidence of foodborne diseases….
Welcome to the final 2020 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…
…Development and the BPCI Act (Nov. 19, 2020). To that end, this guidance provides further draft responses to frequently asked questions about biosimilars and interchangeability. Specifically, the guidance addresses some…
…enforcement discretion policies and exemptions FDA has implemented over the past six months. Sign up for the Digital Health Conference with the discount code save15 for 15% off registration: https://bit.ly/3iMcKa8….
…into PDF format. We are still missing a few of the monthly supplements from the early 1980s. So if you happen to have one of them handy, please send us…
…certification to the ‘063 patent. (Other applicants presumably submitted a Paragraph III certification to the patent.) Ranbaxy is reported to be a first applicant eligible for 180-day exclusivity. BI filed…
…efficiently allocate its resources “to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants.” As Dr. Choe shared in her statement…
…magnitude of the impact is small, but the results strongly statistically significant. Third, there is generally no relationship between the therapeutic category in which a drug falls and the drug’s…
…plaintiff and two of the defendants had appealed and cross-appealed, respectively. The central issue before the Seventh Circuit was whether a Lanham Act claim could proceed when the claim was…
…by [Plaintiffs], i.e., judicious use of medically important antimicrobials.” The draft guidance provides a “framework for policy regarding the appropriate or judicious use of medically important antimicrobial drugs in food-producing…
…the healthcare system. This is so, says the FTC, because, after improperly listing a patent and timely filing an infringement suit, “a brand can generally rely on the automatic stay…