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Titles
- Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff1
- Advancement of emerging technology applications for pharmaceutical innovation and modernization1
- Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases1
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1
- Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice1
- Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- Challenges remain in FDA's inspections of domestic food facilities1
- Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment1
- Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff1
- Compliance policy for required warning statements on small-packaged cigars1
- Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)1
- De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff1
- Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff1
- Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff1
- Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff1
- Drug supply chain security: wholesalers exchange most tracing information1
- E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)1
- Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders1