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Titles
- Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff1
- Technical considerations for non-clinical assessment of medical devices containing nitinol: guidance for industry and Food and Drug Administration staff1
- Temporary policy for compounding of certain drugs for hospitalized patients by outsourcing facilities during the COVID-19 public health emergency (revised)1
- Temporary policy for compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency (revised)1
- Temporary policy for manufacture of alcohol for incorporation into alcohol-based hand sanitizer products during the public health emergency (COVID-19)1
- Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)2
- Temporary policy on Prescription Drug Marketing Act requirements for distribution of drug samples during the COVID-19 public health emergency1
- 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 for biotin interference in in vitro diagnostic devices1
- 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 Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff1
- The MEDIC produced some positive results but more could be done to enhance its effectiveness1
- The Special 510(k) Program: guidance for industry and Food and Drug Administration staff1
- The impacts and implications of COVID-19 on household arrangements1
- The least burdensome provisions: concept and principles : guidance for industry and Food and Drug Administration staff1