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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Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.
Lilly appeared to benefit from agency’s increased familiarity in treating COVID-19 with these types of biologics. Changing nature of the pandemic and the loss of utility of older antibodies due to the Omicron variant may have also played a role in the data required for latest EUA.
FDA commissioner's commitment to counter misinformation also appears to include pledge to ensure agency is driven by science-based decisions, not politics.