…original Opana ER not substitutable, but Endo needed some time to shift the market to its crush-resistant product. To buy some time, Endo sued Impax for patent infringement and triggered…

…lower to consumers at the point of care) with all company profits deriving from a very significant government-funded income stream”; (4) Patent Buy-out Prize Funds; (5) Strategic Antibiotic Reserve (SAR);…

…and other benefits.” Judge Gilstrap didn’t buy Defendants’ argument that the statutory notice provisions at FDC Act § 505(j)(2)(B)(ii), and, in particular, FDC Act § 505 (j)(2)(B)(ii)(II) concerning ANDA amendments/supplements…

…we’re protecting people’s sensitive information via geolocation data that people can buy to track with great precision” said Khan, “whether people are going to addiction facilities or places of worship…

…government agencies, including FDA, it does not speak for all federal agencies (e.g., SEC). Foreign regulators and state and local enforcement agencies must buy into DOJ policy for true effectiveness….

…end product.” According to the Court, based on various provisions of the FAR, “domestic end products” are a subset of “U.S.-made end products.” In other words, a U.S.-made end product…

…lawsuit. The District Court did not buy Genentech’s distinction and dismissed Genentech’s action without prejudice after an oral hearing. The Court’s decision implies that the only recourse Genentech has is…

…(and possibly fraudulent) claim that drinking these soft drinks will promote weight loss.  Without data to support its allegation, USRTK claims that reasonable consumers buy diet sodas, labeled as diet,…

…for its gene therapy program (see previous coverage here). GMP Manufacturing Compliance Appears to be Waived The RMAT draft guidance suggests that clinical trial data can be shared buy multiple…

…– in essence, “don’t buy this product.”  Under what circumstances can the government constitutionally compel a manufacturer to convey such a message?  In the cigarette warning case, the DC Circuit…

…FDC Act (Another section of S. 1438 would repeal the Affordable Care Act’s restriction on the use of health, medical and flexible savings accounts to buy OTC drugs without a…

…it easier to buy and sell goods and services between the EU and the US. The GPhA/EGA letter makes five specific recommendations for inclusion in TTIP: Implement a single development…

…documentation of those same factors, but not to release that information to the public. Shifting to PDUFA VI While BIO’s recommendations could be implemented at any time, to establish buy-in…

…buy, or distribute a Schedule I controlled substance” and using the mail to facilitate committing an act or acts that constitute a felony under the CSA. The letter further states…

…deposits and withdrawals between different accounts. The opinion explains that Banks used bogus information to open accounts at the FOREX.com international exchange system, ostensibly to buy and sell foreign currencies….