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Titles
- FDA oversight2
- Failure to respond to an ANDA complete response letter within the regulatory timeframe1
- Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry1
- Field alert report submission: questions and answers1
- Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry1