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Titles
- A guide for health care advocates: Medicaid managed care procurement1
- A manual of public health nursing1
- A risk-based approach to monitoring of clinical investigations questions and answers: guidance for industry1
- ANDA submissions--amendments to abbreviated new drug applications under GDUFA1
- Acne vulgaris: establishing effectiveness of drugs intended for treatment1
- Action level for inorganic arsenic in apple juice: guidance for industry1
- Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry1
- Adjusting for covariates in randomized clinical trials for drugs and biological products: guidance for industry1
- Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff1
- Advancement of emerging technology applications for pharmaceutical innovation and modernization1
- Allergic rhinitis: developing drug products for treatment1
- Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical: guidance for industry1
- Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry1
- Anthrax: developing drugs for prophylaxis of inhalational anthrax1
- Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases1
- Antibiotic prophylaxis in surgery: a national clinical guideline1
- Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff1
- Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff1
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff1