…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…

…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…

…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…

…asked to clarify this term. Are EPRs the same as “Essential Performance” as defined in IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential…

…served as flypaper for Paragraph IV patent certifications from several ANDA sponsors, including APP Pharmaceuticals, LLC (“APP”), the company embroiled in a battle with MDCO in the Federal Circuit over…

…OZO, OZP, OZQ) Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC ) Automated external defibrillators (e.g., MKJ, NSA ) Duodenoscopes (on the reprocessing; e.g., FDT) with elevator…

…not withdrawn.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…

…listing regulations along the lines the FTC Report suggested.  It also recommended that Congress consider enacting a private right to counterclaim and raise the issue of whether the patent properly…

…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 sup​​plies for administration (e.g., syringes), to any individual without…

…printing to PDF) that states comments will not be sent to FDA. eSTAR allows for responses to additional information (AI) requests. eSTAR guides the submitter in modifying the original submission…

…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…

…getting more of the product than they actually are. A crucial question in slack fill litigation is whether the slack fill in question is truly “nonfunctional.” Under federal law, empty…

…extensions (because the original drug was not an oral dosage form drug), CMS’s bright line rule prevails: a manufacturer may establish a new baseline AMP for a drug only if…

…however, the requirements that remain are substantial and will require further substantive review and approval.  In those cases, the agency expressly requires further action in its approval letter as a…