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…process as required under 42 U.S.C. § 262(l)(2)(A). Additionally, Amgen allegedly insisted that Genentech’s patent counsel could evaluate proposed infringement and withheld consent to expert participation in violation of 42…
…are relatively new devices. Perhaps the most notable proposed exemption, however, relates to drugs of abuse tests. FDA has proposed exempting virtually all drugs-of-abuse testing including those performed by traditional…
…lymphoma (5/30/2012) Treatment of patients with mantle cell lymphoma who have not received at least 1 prior therapy 10/08/2014 (10/08/2021) brentuximab vedotin (Adcetris) Treatment of Hodgkin’s lymphoma (1/30/2007) Treatment of…
…so that a generic drug applicant that has entered into a presumably anticompetitive agreement as detailed in Section 401 is disqualified as a “first applicant.” Additionally, an applicant that did…
…communities who rely on them.” Calling the Final Guidance “regulatory overreach,” the Letter lastly seeks the rescission of the Final Guidance, and requests FDA to issue a proposed rule that…
…covers only the differences from a previously approved product, as a practical matter a later-approved product is likely to have a narrower scope of exclusivity than the product approved previously.…
…applications and PASs (i.e., $74,934,000), largely explaines the nearly 30% fee rate increase over FY 2015. FDA figures show a downward trend in ANDA and PAS submissions. (See here for…
…or improper payment of GDUFA user fees, inadequate stability data, dissolution data or bioequivalence data (even failed studies), and incomplete or untimely responses to minor deficiency communications. While OGD certainly…
…applications – 2,136 as of June 2010 (approximately 1,600 of which have been pending for more than 180 days). And the backlog continues to grow. So OGD has apparently decided…
…safe and effective generics. Such deals can cost consumers billions of dollars because generic drugs are typically priced significantly less than their branded counterparts. The Administration’s proposal will generate $11…
…company is the only first applicant eligible for 180-day exclusivity. There has been quite a bit of patent infringement litigation over the DETROL LA Orange Book patents involving various ANDA…
…PRN Publishing, requiring the application number on drug product labels would allow pharmacists “to quickly and easily determine the equivalence status of any drug product by simply comparing the [application]…
…and (3) Exclusivity (presumably carefully worded to avoid another tussle over “market” versus “data” exclusivity – see our previous post here). Many of the questions are drafted to elicit an initial…
By Kurt R. Karst – It seems that hardly a day goes by without something new happening concerning patent settlement agreements. They are generally referred to as “pay-for-delay” agreements; however,…
…may be helpful in understanding the genesis of this recently released report. In response to concerns raised by industry, consumer groups, and CDRH employees, CDRH began an evaluation of its…