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…for procedural sedation despite the fact that use for procedural sedation may at times occur in an intensive care setting. Use in an intensive care setting is not expressly disclosed…
…additional designation requests for the drug to cover these additional indication(s) or use(s) – because they would fall within the original designation. Additional orphan-drug exclusivity may attach upon approval of…
…“a potential market entrant to perform the experimental conduct necessary to engage in the development of information to submit to the FDA to obtain FDA approval of commercial sales –…
…. . . .” KV has also sued state Medicaid agencies in Illinois, Georgia, and South Carolina to cover MAKENA. In early August, KV won the Georgia case (see here)….
… $60 Current and Proposed Fees for Annual Cycle Registrants Registrant Category Current Annual Fee Proposed Annual Fee Increase Per Year Researcher/Canine Handler $184 $244 $60 Analytical Lab…
…Narcan Nasal Spray (NNS) is “supportive of its use as a nonprescription opioid overdose reversal agent.” FDA Commissioner Robert M. Califf, M.D. announced that “Today’s approval of OTC naloxone nasal…
…additional information should be included in the report, such as the National Clinical Trial (“NCT”) number assigned to a study when the study is registered with ClinicalTrials.gov. FDA intends to…
…is no mechanism to import personal protective equipment for a medical use (Gloves, Gowns, Surgical Apparel, etc.,) that is not in compliance with traditional medical device requirements, even if FDA…
…storm warnings stemmed from a study called the Vioxx Gastrointestinal Outcomes Research (“VIGOR”) study, which showed an increase of myocardial infarction in patients treated with Vioxx as compared to naproxen. …
As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing…
…any given case. For example, the FTC cannot seek restitution or disgorgement in administrative litigation (although it can pursue such remedies in federal court after a final administrative order has…
…false certifications that the products met safety standards. Even though the government touts this case as the “First-Ever Criminal Prosecution for Failure to Report” under the CPSA, the allegations describe…
On April 26, 2019, CDRH released the final guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions (“Final Guidance”). We previously blogged on the draft…
…Legislative Calendar under General Orders where it remains. The newly introduced H.R. 3443 contains the same language as the monograph section of the Pandemic and All-Hazards Preparedness and Advancing Innovation…
…been criticized. Or a more cynical view could be that all the discussion of “deference” is merely a judicial cover to achieve a predetermined result in favor of the agency….