Antibiotics Legislation Could Boost Confidence Of Sponsors And FDA Alike
A limited population antibacterial drug pathway could reassure investors about the viability of antibiotics and help FDA avoid looking over its shoulder as it approves products based on limited data, though enactment is uncertain.
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FDA Anti-Infective Drugs Advisory Committee cites need to prevent widespread prescribing but acknowledges poor antibiotic stewardship by the medical community; legislation could give FDA additional tools to regulate use and post-marketing surveillance.
At the final roundtable for the 21st Century Cures initiative in Washington, Chairman Upton promises swift action, and urges stakeholders to submit their ideas “as soon as possible.”
Point-of-care diagnostics can make antibiotic development faster, easier and cheaper, but creating them will be a bumpy ride, according to a recent discussion among government and industry officials.