1. Food Safety: a national strategy is needed to address fragmentation in federal oversight : report to Congressional requesters
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2. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy
3. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications
4. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders
5. 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
6. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)
7. Q3C--tables and list
8. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards
9. M4E(R2): the CTD--efficacy
10. Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)
