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- ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs1
- Adjusting for covariates in randomized clinical trials for drugs and biological products: guidance for industry1
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1
- Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff1
- Benefit-risk assessment for new drug and biological products: guidance for industry1
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