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…8126. Under the latter statute, manufacturers of “covered drugs” (generally, prescription drugs approved under a new drug application) must, in order for their outpatient drugs to be federally reimbursed under…
…dramatically increasing the industry’s commercial ability. Letter 2: Top Ten Reasons for Rescheduling Cannabis to Schedule III From: Democratic State Attorneys General Date: January 12, 2024 Twelve state attorneys general…
…proposed in this regulation, but the most noteworthy are described below, roughly in order of importance. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average…
…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…
…December 31, 2019 court-ordered discovery deadline for FDA to produce documents, which the agency failed to meet. FDA says it needs until April 30, 2020. We blogged about the prior…
…“to directly perform” the fourth and fifth functions as well. Id. So, to comply with the Single Convention, the regulations, if finalized, would require: Registered manufacturers to deliver the entirety…
…DoD’s authority”), but offers only cold comfort: if a manufacturer thinks an opt-out will put it in breach of its Master Agreement, the manufacturer can always voluntarily decide to terminate…
…not meet the MC-to-PC regulatory threshold. Raptor, however, was not deterred. The company came up with a new MC-to-PC theory: the company’s enteric-coated cysteamine causes less halitosis and body odor…
…communications with Cody/Lannett, FDA stated that the Agency would exercise enforcement discretion with regard to the shipment and distribution of Cody’s/Lannett’s unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products until…
…alleged violation, CDER stated that: “[w]e found that controls on your computerized chromatographic instrumentation were not adequate to prevent analysts from manipulating processing parameters in order to obtain passing results….
…Patent No. 6,087,380 (“the ‘380 patent) covering Boehringer’s PRADAXA (dabigatran etexilate) Capsules (NDA 022512). The Complaint was prompted by a December 2014 PTE regulatory review period decision in which FDA…
…other patents related to ZILVER PTX: U.S. Patent No. 6,299,604 (Docket No. FDA-2013-E-0677); U.S. Patent Nos. 6,515,009 (Docket No. FDA-2013-E-0681); and U.S. Patent No. 7,820,193 (Docket No. FDA-2013-E-0676).) Element number…
…court action seeking restitution and other remedies after it issued a cease and desist order and the order becomes final. POM potentially faces a restitution action for millions of dollars….
…treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder. Id. at 16. As we noted previously, the guidelines are reasonable…
…a lawsuit targeting coffee-creamer products containing partially hydrogenated oil (PHO) on preemption grounds. The complaint – one of several similar complaints targeting PHO-containing products – asserted nine causes of action…