…Clinical usability or human factor studies may also be required, depending on the indication and the patient population, the nature of the auto-injector design, and differences from the auto-injector constituent…

…intended for emergency use, if appropriate.”  Indeed, in the case of sumatriptan auto-injectors, FDA noted that “individuals experiencing migraines . . . may experience varying degrees of mental impairment, and…

…the mere act of issuing a Form 482, and that FDA does not need the actual consent of the establishment or a judicial warrant to enforce that right. Few companies…

…Superior Court’s non-precedential decision relied on federal preemption principles to affirm the trial court’s dismissal of Appellant’s second amended complaint with prejudice. Appellant brought wrongful death and survival claims individually…

…that line-extension provision, a manufacturer that introduces a line-extension drug with a new baseline AMP must pay the greater of the rebate calculated in the ordinary manner, or an alternative…

…added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., NDA or BLA) drugs. Under that provision, a manufacturer that introduces a line extension…

…13th meeting, Clinical Trials: The Patient Experience, promises to continue the education of all of us on the patient experience with, and preferences for, gene therapies and their clinical trials….

…government healthcare programs for Gamunex. According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection…

…relevance of the animal studies for purposes of the IDE study.  This is unfortunate because there is no way to judge whether the omitted animal studies were clearly relevant, or…

…expanded vaccine that treats all of the bacterial strains covered by the original vaccine plus additional ones.  Like the original, the expanded vaccine is the only FDA-approved pneumococcal conjugate vaccine…

…This could occur, for example, as different disease stages or different lines of therapy are approved. (Some possible examples of this might be in the cases of Ibrutinib, Cinacalcet, Bortezomib,…

…metal/metal semi-constrained, with a cemented acetabular component, prosthesis. 22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. 23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses)….

…exclusive approval, as appropriate, for those additional subsets from the date of such additional marketing approval(s). Before obtaining such additional marketing approval(s), the sponsor in this instance would not need…

…also extends to include unassuming corporate officers whose companies engage in unlawful activities under the FDCA.  As such, the government can seek to obtain misdemeanor convictions of a company official…

…violation of federal laws, and threatening criminal prosecution if corrective action is not implemented.  Contact lenses (including decorative/color and corrective lenses) are regulated as medical devices pursuant to section 520(n)…