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…notice of NDA approval of the drug product if that transmittal occurs after normal business hours. In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that…
…drug as an “antibiotic” (see here). Second, there’s the recent fight over whether the St. Regis Mohawk Indian Tribe can use tribal sovereign immunity to shield patents covering RESTASIS from…
…in the drug/biological product approval process SEE the importance of cGMPs to the post-approval regulatory process NAVIGATE the protocols of adverse events monitoring, pharmacovigilance, and Risk Evaluation and Minimization Strategies…
…agenda item for Massachusetts lawmakers for several years now, and is intended to help Massachusetts-based The Medicines Company, which submitted its PTE application for U.S. Patent #5,196,404 (“the ‘404 patent”)…
…that transmittal occurs after normal business hours. In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that would mean the 60-day period would have begun on…
…(“the ‘338 patent”), which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a PTE on the same two statutory bases. In both cases, AstraZeneca has challenged…
…in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I). The MMA also added an almost identical counterclaim provision at FDC Act §505(c)(3)(D)(ii)…
…a model drug facts label (DFL) for OTC naloxone and published a label comprehension study and model DFLs for naloxone administered via nasal spray and auto-injector in 2019. In November…
…CDRH Customer Collaboration Portal (CDRH Portal). This builds on the progress tracker launched in 2021 for 510(k) submissions and allows anyone to register for a CDRH Portal account to send…
…automatic construction and auto-filling content; content and structure that is complementary to CDRH internal review templates; integration with FDA databases and guidance documents; and automatic verification. While eSubmitter is a…
…article also cited to two FDA cases that concluded that FDA could not ordinarily compel an inspection of a regulated company without a warrant unless FDA obtained the consent of…
…not claim either – (aa) the drug for which the application was approved; or (bb) an approved method of using the drug. The MMA also added an almost identical counterclaim…
…not withdrawn. Although Antares raised in its petition, among other things, choice of listed drug and pharmaceutical equivalence issues, all FDA needed to deny the petition was to answer one…
…just an individual patient. For example, the Maryland standing order allows all Maryland licensed pharmacists to dispense naloxone, including any necessary supplies for administration (e.g., syringes), to any individual without…
…and best of all, the American people will save money, and yet receive the best medicine that pharmaceutical science can provide”? A: Q2: Why is the “Orange Book” cover Orange?…