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…prescription drugs, including but not limited to, owned, acquired, affiliates, brother or sister corporations, operating subsidiaries, franchises, business segments, part of holding companies, divisions, or entities under common corporate ownership…
…in the recent case of Peter F. Kelly, D.P.M., 82 Fed. Reg. 28676 (June 23, 2017), DEA has created a litany of new duties on questionable statutory or regulatory basis….
…in the Joint Motion to Stay, the plaintiffs (the Association of Community Cancer Centers, the National Infusion Center Association, the Global Colon Cancer Association, and PhRMA) and government defendants agreed…
Under the Public Readiness and Emergency Preparedness Act (“PREP Act”), manufacturers, distributors, and health care providers acting to address the COVID-19 crisis can be protected from products liability suits related…
…of administration. FDA also advises, however, that for cellular and gene therapies, blood products, vaccines and other complex biological products regulated by the Center for Biologics Evaluation and Research (“CBER”),…
…patent upon approval of the product. In the veterinary world, where rolling applications are common, the testing phase is usually particularly important because the review phase, which starts only when…
…about each transaction involving a tableting machine, including the date, name and address, quantity, method of transfer, etc. 21 C.F.R. § 1310.06. Also, pursuant to 21 U.S.C. § 830(b) and…
…LDTs (see, e.g., prior posts here, here, here, here, and here). HHS’s announcement has far-reaching implications for all clinical laboratories offering LDTs, which we will explore in future blog posts….
…rule would cause patient, pharmacy, and supply chain disruptions, the OIG moved the effective date to January 1, 2022. The proposed rule comment period was set to close on April…
…likely to succeed on the merits because the government failed to comply with, and did not have good cause to ignore, the Administrative Procedure Act’s notice and comment requirement. Finally,…
…delayed effective date of January 1, 2022, while the two new safe harbors were scheduled to go into effect on January 29, 2021 (last Friday). However, since Friday, both the…
…first time on appeal, and is therefore, waived. In a footnote, however, the majority described this argument as “dubious at best.” The majority asserted that the district court order requires…
…the manufacturer represented that Medicare beneficiaries have not, and likely will not, qualify for the program. However, beneficiaries of other Federal health care programs, including Medicaid and TRICARE, may qualify…
…a poorly thought-out rule that, if implemented, will render virtually unusable the current best price exclusion for manufacturer patient savings programs in the form of coupons, patient rebates/refunds, copay assistance,…
End-of-Phase 2 (EOP2) is, in our view, one of the most critical moments in drug development. It’s the moment at which a drug sponsor selects, and seeks FDA agreement on,…