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…New York issued nationwide preliminary injunctions, while the District Court for the District of Maryland issued a temporary restraining order. Each order effectively blocked the MFN rule from taking effect…
…drug as a non-innovator multiple source drug), but also reporting other “drug product information . . . that is not supported by the statute and applicable regulations.” The preamble provides…
…and policy issues raised by the rule. On Saturday — the very next day — the new discount safe harbor exclusion was also delayed, this time by court order. Earlier…
…scratching their heads and unsure as to what FDA expects in EUAs moving forward. The next “FDA Virtual Townhall” is Wednesday March 24th at 12:15 pm (ET). See you there….
…the drug’s REMS. The pharmaceutical manufacturer is responsible for certifying the health care facilities where the drug can be administered. Typically, the drug is administered only once. In order to…
…of a drug’s price offered to health plans. The complaint seeks a ruling that the amendment is invalid and an injunction against its implementation. ¶¶ 49-63. 2. CMS Proposes to…
…not be an appropriate subject for a formal dispute resolution request (FDRR) by a sponsor.”). In limiting the scope of FDRRs in this way, the Agency comforted itself that meeting…
…to help companies comply with FDA’s requirements. That strategy has failed, too. The new idea is for NIH’s ITAP program to pivot to serial screening. NIH has been in communication…
…patients do not qualify as best-price-eligible entities. See 85 Fed. Reg. 87000, 87052 (Dec. 31, 2020). Therefore, “[a] manufacturer’s financial assistance to a patient does not count as the lowest…
…the purposes of this Guidance. While certain states do define “harm reduction programs” (e.g., West Virginia), there is no such definition in FDA regulations or in the DSCSA. When ordering…
…is waiting to hear from you, so provide your comments before the docket closes in February. In the words of the esteemed Dr. Frasier Crane, the USPTO says: “I’m listening.”…
…civil complaint against GoodRx for data privacy breaches. The case includes a proposed order that may sharply narrow the company’s ability to traffic in consumer data, often a key part…
…restitution. On the Commission’s motion, the district court issued a temporary injunction, froze Brown’s assets, and appointed a receiver to manage his company. Brown and the Commission later filed cross-motions…
…on FDA’s “scientific and medical conclusions.” Letter to DEA Administrator Anne Milgram, from Phil Weiser, et al., (Jan. 12, 2024). The authors view such rescheduling “as a public safety imperative…
…83 Fed. Reg. 12027, 12028 (Mar. 19, 2018). The Acting Administrator noted that there was no evidence in the record as to when the doctor received the OSC. As such,…