U.S. Department of Health & Human Services

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


2. 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


4. 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


5. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases


8. Bioanalytical method validation