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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.  Food and Drug Administration (FDA) Final
Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format -- Standardized Study Data  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format — Content of Labeling  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format--Receipt Date  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format; General Considerations  Food and Drug Administration (FDA) Final
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