« Previous
Next »
Titles
- Recognition and withdrawal of voluntary consensus standards: guidance for industry and Food and Drug Administration staff1
- Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff1
- Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff1
- Recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease by blood and blood components1
- Referencing approved drug products in ANDA submissions2
- Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff1
- Regulatory considerations for microneedling products: guidance for industry and Food and Drug Administration staff1
- Requesting FDA feedback on combination products: guidance for industry and FDA staff1
- Resuming normal drug and biologics manufacturing operations during the COVID-19 public health emergency1
- Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency1
- Revised recommendations for reducing the risk of human immunodeficiency virus transmission by blood and blood products1
- Revised recommendations to reduce the risk of transfusion-transmitted malaria1
- Risk evaluation and mitigation strategies: modifications and revisions1
- Rural hospital closures: affected residents had reduced access to health care services : report to the ranking member, Committee on Homeland Security and Governmental Affairs, United States Senate1
- Rural hospital participation in Medicare accountable care organizations1