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Titles
- Temporary policy on repackaging or combining propofol drug products during the COVID-19 public health emergency1
- Temporary policy regarding accredited third-party certification program onsite observation and certificate duration requirements during the COVID-19 public health emergency1
- Temporary policy regarding non-standard PPE practices for sterile compounding by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency1
- Temporary policy regarding preventive controls and FSVP food supplier verification onsite audit requirements during the COVID-19 public health emergency: guidance for industry1
- Tennessee Medicaid Fraud Control Unit: 2017 onsite inspection1
- Testing and labeling medical devices for safety in the magnetic resonance (MR) environment: guidance for industry and Food and Drug Administration staff1
- Testing for biotin interference in in vitro diagnostic devices1
- Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol: guidance for industry1
- Testing of retroviral vector-based human gene therapy products for replication competent retrovirus during product manufacture and patient follow-up1
- The "deemed to be a license" provision of the BPCI Act: questions and answers1
- The 2018 long-term budget outlook1
- The 2019 long-term budget outlook1
- The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff1
- The Children's Health Insurance Program (CHIP): the fundamentals1
- The Food and Drug Administration needs to improve the premarket tobacco application review process for electronic nicotine delivery systems to protect public health1
- The MEDIC produced some positive results but more could be done to enhance its effectiveness1
- The Medicaid Drug Rebate Program: the basics1
- The Medicare and Medicaid Improvement Funds: budgetary history and projections1
- The Medicare drug benefit (Part D): the basics1
- The Medicare drug benefit coverage gap: the basics1