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Jeffrey K. Shapiro of Hyman, Phelps & McNamara, P.C. will be speaking at American Conference Institute’s 8th National Conference on Reducing Legal Risks in the Sale and Marketing of Medical…
…sixty-day period begins on the FDA approval date.” Notwithstanding the specific language in 35 U.S.C. § 156(d)(1) and the Federal Circuit’s commentary in the Unimed decision, AstraZeneca asserts with respect…
…. . [a paragraph IV certification for the drug] [hereinafter the “submit” prong] and [3] lawfully maintains a [paragraph IV certification] for the drug [hereinafter the “lawfully maintains” prong]. Under…
…the patent.” (The company’s most recent annual report reiterates this.) This alternative took the form of lobbying Massachusetts lawmakers to push for legislation that would provide the PTO with discretion…
…(later amended) Allergan, Inc. (“Allergan”) filed alleging premature notice concerning generic RESTASIS (cyclosporine ophthalmic emulsion) 0.05%. Allergan was seeking, among other things, a “Declaratory Judgment of False Paragraph IV Notification”…
…practical real-world examples that will help you to excel in your everyday practices. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks!…
…review period occurred for commercial marketing or use” (i.e., within 60-days of the date of NDA approval). In April 2007, the PTO denied the PTE request. Among other things, the…
…outreach; Identifying additional sources of diversion; Collaborating investigations with state and local entities; Expanding the use of Tactical Diversion Squads (“TDSs”) (comprised of DEA diversion investigators and special agents, state…
…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…
…the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use” (i.e., within 60-days of the date of NDA…
…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…
…checklist, but the general structure has been constant. This method of submission development allows for efficient development of each section and collaboration across numerous subject matter experts and internal reviewers….
…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…