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…a 60-day period calculated using the date after product approval as day 1. AstraZeneca also cites: (1) a 1987 PTO-FDA interagency memorandum of understanding stating that in response to a…
…NDA approval, “[b]y not counting the date of FDA approval as one of the sixty days included in the time period for filing a PTE application, the USPTO was failing…
…the statute, FDA recently promulgated binding regulations—after formal notice-and-comment rulemaking—that not only affirmed its longstanding position, but expressly relied on the court cases upholding that well-settled rule. Abbreviated New Drug…
…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…
…and local law enforcement and regulatory officers conducting criminal investigations); Scheduling drugs of abuse; Establishing controlled substance and listed chemical quotas; and Employing sufficient personnel to fulfill DEA’s regulatory and…
…basics of current FDA law and regulation — including the nuances of the FDA Amendments Act. They will help you: MASTER the basics of the application and approval processes for…
…legal parameters of DTC marketing, including “new media” TRACK state legislative initiatives and HARMONIZE inconsistent state obligations Additional details and registration information are available at www.AmericanConference.com/MedicalDevices or by calling 888-224-2480….
…savings in hospital costs accruing in the FY2019-FY2028 period would result in net federal budget savings over the 20-year period, FY2009-FY2028, even under the CBO assumptions. Further, using the assumptions…
…added). Could the parenthetical language at FDC Act § 505(c)(3)(C)(i) include a court-ordered patent delisting? After all, such a delisting would seem to mean that there is no cause of…
…be identified in various ways, including through guidance, special controls, and classifications, as well as by individual reviewers on a case by case basis. The latter method is troubling. The…
…a lodging association had commenced a suit seeking declaratory and injunctive relief by making a facial challenge to a Los Angeles ordinance that requires hotel operators to make their registries…
…application for Loratadine Tablets, 10 mg, FDA determined that an intervening NDA approval for the same drug product does not bar the Agency from approving a pending 505(b)(2) application. Specifically,…
…requests in an eCopy format. The eSTAR templates can also be used to respond to requests for additional information. When entering the template, the user can select “additional information” as…
…expanding availability and access to overdose reversal products, including naloxone, by supporting accelerated product review and “exploring over-the-counter access.” Many states already have standing orders that allow for the dispensing…
…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…