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…the grounds that whatever else it represented, what the agency did was not final agency action. In the Sackett case, the government argued that EPA compliance orders were not final…
…opinion in PLIVA Inc. v. Mensing (Docket No. 09-993), Actavis Elizabeth, L.L.C. v. Mensing (Docket No. 09-1039), and Actavis, Inc. v. Demahy (Docket No. 09-1501). It happened at 10:15 AM….
…order)) and PROVIGIL (modafinil) (Fed. Trade Comm’n v. Cephalon, No. 08-cv-2141-RBS (E.D. Pa. May 8, 2008) (transfer order)), respectively. Other findings discussed in the report include the following: “Agreements with…
Last month, former Theranos executives, Elizabeth Holmes and Sunny Balwani, convinced U.S. District Judge Davila to throw out criminal fraud charges, while denying other defense motions (see Judge Davila’s order…
…triggering purposes. Several years later, in Teva Pharm., USA, Inc. v. FDA, 398 F. Supp. 2d 176 (D.D.C. 2005), Teva challenged an FDA decision that a dismissal of a declaratory…
…5,376,634, 6,265,536, or 6,107,458 for NDA No. 21-506, and one for either of these same patents for NDA No. 21-754 – but ultimately decided not to elect a second PTE. …
…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…
…more than 30 months from March 22, 2005 [when the first ANDA was submitted], no first applicant’s ANDA has been approved. Also, on April 16, 2007, Bayer requested that [U.S….
…Date: January 29, 2024 Twelve Democratic senators signed Letter 3. Five of the senators (Elizabeth Warren, Cory Booker, Bernie Sanders, Kristen Gillibrand, and Ron Wyden) wrote to the Attorney General,…
…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…
…was based on the “overlap” in the definition of drug and device. The Act, in relevant part, defines “drug” to include: articles intended for use in the diagnosis, cure, mitigation,…
…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…
…according to Sanofi, are studies intended “to demonstrate safety and effectiveness,” rather than, as FDA argued, chemistry, manufacturing, and control information); (2) FDA departed from Agency precedent by approving ANDA…
…Tobacco Control Act. Last week, the agency issued the much anticipated proposed deeming regulations that would cover electronic cigarettes (“e-cigarettes”), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and…
…in interstate commerce,” and that such a drug is adulterated since Regenerative is not complying with current Good Manufacturing Practices. The Government further argues that, as a drug, Regenerative’s stem…