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…the results that consumers can generally expect. In addition, the FTC has now made it clear that advertisers must clearly disclose “material connections” between the advertiser and the person endorsing…
…recently ruled and issued an Order and Injunction requiring Novo Nordisk, Inc. (“Novo”) to change an Orange Book-listed patent use code for a patent (U.S. Patent No. 6,677,358 (“the ’358 patent”)) on…
…FDA (as previously noted, approximately two-thirds of these petitions are denied in full). Accordingly, it is FDA’s view that this provision has neither curbed the filing of petitions submitted with…
…more likely to be included in Medwatch and 5.7% more likely to receive a black-box warning. These results, in and of themselves, are not particularly concerning, but it’s not entirely…
…browse alphabetically rather than search (and there are 1685 of them for your reading pleasure). As exciting as the new website is, FDA really buried the lead when it announced…
…unexpected. This is because generic and innovator sponsors both rely heavily on the Orange Book patent listings but typically for different purposes. That they would have different opinions—and that combination…
…monitoring and signal detection Recalls, product withdrawals, and FDA oversight authority FDA Boot Camp is taking place virtually from March 22-23, 2023, visit http://bit.ly/3WxcEHs to learn more! Save 10% with…
…be helpful. Prior to the Guidance, FDA had sometimes allowed so‑called split predicates in 510(k)s. A split predicate was one “using one legally marketed device for intended use and a…
…the Orange Book. Though only one question long, the Petitioned ANDAs section packs a lot into a single paragraph. The question essentially asks how Petitioned ANDAs—ANDAs for which FDA has…
…product in a ready-to-use solution and therefore are not pharmaceutically equivalent—and accordingly not therapeutically equivalent—products. Drug products in different packaging may be therapeutically equivalent, but it depends on whether the…
…Really, FDA and the PTO only interact in the context of patent term extensions, in which the PTO relies on FDA to determine the dates of the applicable regulatory review…
…the Agency’s long history of treating PANDAs “similarly to 505(j) ANDAs . . . over the decades after the enactment of the Hatch-Waxman Amendments.” But FDA only recently requested comments…
…halls of Congress looking for advocates for its own causes. Usually FDA’s lobbying activities are done rather quietly. Every once in a while, however, FDA is a bit bolder in…
…we mean really Bad and really Ugly!) things too—come to those who wait! But before we get back to “the Good” again, let’s take a look at “the Bad” and…
…years, respectively, after publication of the final rule. State licensing requirements that currently apply to WDDs and 3PLs will only be preempted once the Proposed Rule is finalized and takes…