US FDA Eyes New Investigational Drug Label Requirements That Bring International Harmonization
To help reduce medication errors that can harm patients and compromise research results, FDA – pushed by clinical trial sites – looks to exert more control of the labels of investigational drug products.
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Surprising move to have VRBPAC debate offering mRNA boosters to everyone 18 and up, less than one month after the panel shot that down for Pfizer’s vaccine, thus stalling the White House’s plan for a broad booster rollout, was driven internally by the FDA, a senior health official said.
Though not designed to facilitate inter-group comparisons, a preprint study of heterologous and homologous boosting with the three US available COVID-19 vaccines indicate Johnson and Johnson primary vaccines may get greater protection from an mRNA booster.
Johnson and Johnson’s one-shot Covid vaccine gets a solid efficacy boost with second shot administered two months after primary vaccination, but the company will argue based on much more limited data that a longer window between shots may be preferable for some populations.