1. ANDA submissions--amendments to abbreviated new drug applications under GDUFA
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2. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases
3. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice
4. Bioanalytical method validation
5. Elemental impurities in drug products
6. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff
7. Formal dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice
8. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products
9. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance
10. How to prepare a pre-request for designation (pre-RFD)
