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Titles
- Compliance policy for required warning statements on small-packaged cigars1
- Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry1
- Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring: guidance for industry and Food and Drug Administration staff1
- Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance1