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| HHS/FDA | RIN: 0910-AC52 | Publication ID: Spring 2005 |
| Title: Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics | |
| Abstract: The Food and Drug Administration (FDA) is proposing to amend the regulations governing the format in which clinical study data (CSD) are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that CSD submitted for NDAs, ANDAs, BLAs, and their supplements and amendments be provided in electronic format and require the use of standard data structure, terminology, and code sets. The proposal would improve the efficiency of the exchange of information from clinical studies through the adoption of standards for study data submitted in an electronic form that FDA can process, review, and archive. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: Undetermined | Unfunded Mandates: No |
| CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94 | |
| Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Undetermined |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
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Agency Contact: Nicole K. Mueller Regulatory Counsel Department of Health and Human Services Food and Drug Administration Room 3037, (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6312, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3507 Fax:301 827-8440 Email: nicole.mueller@fda.hhs.gov |
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