US FDA Waives Warning Cap Requirement For Neuromuscular Agents As Demand Outranks Safety Worries
COVID-driven supply shortages were both the cause of and solution to production deficiencies for manufacturers of neuromuscular blocking agents; US FDA is permitting Mylan, Gland, and Fresenius Kabi to distribute vecuronium bromide and rocuronium bromide even though they do not have the ‘paralyzing agent’ warning on the caps since the products are in high demand at ICUs. The appropriately embossed caps were unavailable due to supply chain disruptions caused by the pandemic.
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Agencies seek public comment on how they can modernize merger guidelines to enforce antitrust laws. List of questions, including what types of evidence show that a merger could reduce competition, indicate pharma and other mergers will face greater scrutiny.