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…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…
…FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status. All 19 members of the joint Advisory Committee agreed that the benefit-risk profile of Narcan Nasal…
…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…
…process.) eSTAR submissions are automated (e.g., form construction, auto filling). eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing….
…not withdrawn.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…
…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)…
…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…
…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…
By John R. Fleder – Although there are many areas where practitioners and others disagree regarding the FDC Act, there is at least one subject that seems to generate universal…
…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…
…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….