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| HHS/FDA | RIN: 0910-AG13 | Publication ID: Spring 2010 |
| Title: Premarketing Safety Reporting Requirements for Human Drug and Biological Products | |
| Abstract: The Food and Drug Administration (FDA) has undertaken revisions to 21 CFR 312.32, 312.64, and 320.31 to better protect public health and improve safety reporting by increasing the quality of safety reports, expediting FDA’s review of critical safety information, advancing worldwide consistency in the collection and submission of safety information, and strengthening the agency’s ability to monitor the safety of certain human drugs and biological products. The final rule amends the premarketing safety reporting requirements for human drugs and biological products to codify the Agency's expectations for timely acquisition, evaluation, and submission of relevant and useful safety information, to improve the overall quality of safety reporting, to implement internationally consistent definitions, to subject bioavailability and bioequivalence studies to safety reporting requirements, and to make other minor revisions. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. FDA plans to finalize the premarket and postmarket safety reporting requirements in separate final rules. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 312; 21 CFR 320 | |
| Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and 263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360b to 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Carol Drew Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6306, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 |
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