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1. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy

nlm:nlmuid-101704830-pdf

2. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

nlm:nlmuid-101704838-pdf

3. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

nlm:nlmuid-101712946-pdf

4. 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

nlm:nlmuid-101712948-pdf

5. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

nlm:nlmuid-101712951-pdf

7. 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

nlm:nlmuid-101713098-pdf

10. 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

nlm:nlmuid-101713196-pdf