Antibiotic Limited Use Claims Present Challenge Of Actually Limiting Use
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.
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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.
Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.
The use of various acronyms – including RRA, RIE and RRR – to describe remote assessments of sites and study data has been confusing and makes it sound as though people are speaking ‘like a pirate,’ Office of Study Integrity and Surveillance director Sean Kassim says.