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Titles
- Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry1
- 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
- Drug-free community support program: agencies have strengthened collaboration but could enhance grantee compliance and performance monitoring : report to Congressional committees1
- 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
- Entities generally met Federal Select Agent Program internal inspection requirements, but CDC could do more to improve effectiveness1
- Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)1
- 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
- Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops1
- Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff1
- Medical x-ray imaging devices conformance: guidance for industry and Food and Drug Administration staff1
- New Jersey could better ensure that nursing homes comply with federal requirements for life safety, emergency preparedness, and infection control1
- No free lunch?: current challenges facing National School Lunch and School Breakfast Programs1
- OHRP generally conducted its compliance activities independently, but changes would strengthen its independence1
- Wholesale distributor verification requirement for saleable returned drug product: compliance policy1