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…minimal safety standard, but did in fact “establish both ‘floor’ and ‘ceiling’.” Although it might be said that this preamble was a politically motivated legal opinion about statutory construction and…
…(bb) an approved method of using the drug. The MMA also added almost identical counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) applicable to ANDA sponsors. Both counterclaim provisions refer to FDC…
…alleged to be a drug delivery device patent has already led one company to assert in court the patent delisting counterclaim provisions at FDC Act §505(c)(3)(D)(ii)(I) added to the statute…
…of the historical background that spurred Congressional action here, including national security risks highlighted by U.S. Departments of Defense (DoD) and Commerce actions against several specific Chinese biotechnology companies. An…
…dramatic effect on import alerts. FDA issued 28 quality-related import alerts in 2022, and most of those 28 alerts were for hand sanitizers that contained impurities or had other defects….
…drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation (here). We find it all rather interesting. After all, data can provide an informative…
…by potential generic competitors, but the FDA mayor may not decide to give final approval to competing generics and it mayor may not decide to give final approval in a…
…62 days after NDA approval (including the December 15, 2000 date of approval). Under 35 U.S.C. § 156(d)(1), the submission of a PTE application must occur “within the sixty-day period…
…outreach; Identifying additional sources of diversion; Collaborating investigations with state and local entities; Expanding the use of Tactical Diversion Squads (“TDSs”) (comprised of DEA diversion investigators and special agents, state…
…Hyman, Phelps & McNamara, P.C.) and Stacy Cline Amin (Partner, Morrison & Foerster (Former Chief Counsel, U.S. FDA)) as they lead an all-star faculty in providing you and your team…
…review period occurred for commercial marketing or use” (i.e., within 60-days of the date of NDA approval). In April 2007, the PTO denied the PTE request. Among other things, the…
…the law.) However, there is a cost for unintentional delay. The bill states that “[i]n order to effect a [PTE] under section 156(i) of title 35, United States Code, the…
…legal parameters of DTC marketing, including “new media” TRACK state legislative initiatives and HARMONIZE inconsistent state obligations Additional details and registration information are available at www.AmericanConference.com/MedicalDevices or by calling 888-224-2480….
…(emphasis added). The 60-day filing period is a hard and fast rule. (At least unless Congress passes the latest iteration of the “Dog Ate My Homework Act,” which would amend…
…the patent.” (The company’s most recent annual report reiterates this.) This alternative took the form of lobbying Massachusetts lawmakers to push for legislation that would provide the PTO with discretion…