Investigational new drug applications; clinical holds--FDA. Direct final rule.
Fed Regist. 1998 Dec 14; 63(239):68676-8.FR

Abstract

The Food and Drug Administration (FDA) is amending its regulations governing investigational new drug applications (IND's) for human drug and biological products. This action amends the IND clinical hold requirements to state that the agency will respond in writing to a sponsor's request that a clinical hold be removed from an investigation within 30-calendar days of the agency's receipt of the request and the sponsor's complete response to the issue(s) that led to the clinical hold. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives significant adverse comments and withdraws this direct final rule.

MeSH

Drug ApprovalDrugs, InvestigationalGuidelines as TopicPolicy MakingUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10187558

Citation

"Investigational New Drug Applications; Clinical holds--FDA. Direct Final Rule." Federal Register, vol. 63, no. 239, 1998, pp. 68676-8.

Investigational new drug applications; clinical holds--FDA. Direct final rule. Fed Regist. 1998;63(239):68676-8.

(1998). Investigational new drug applications; clinical holds--FDA. Direct final rule. Federal Register, 63(239), 68676-8.

Investigational New Drug Applications; Clinical holds--FDA. Direct Final Rule. Fed Regist. 1998 Dec 14;63(239):68676-8. PubMed PMID: 10187558.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Investigational new drug applications; clinical holds--FDA. Direct final rule. PY - 1998/11/16/pubmed PY - 1998/11/16/medline PY - 1998/11/16/entrez SP - 68676 EP - 8 JF - Federal register JO - Fed Regist VL - 63 IS - 239 N2 - The Food and Drug Administration (FDA) is amending its regulations governing investigational new drug applications (IND's) for human drug and biological products. This action amends the IND clinical hold requirements to state that the agency will respond in writing to a sponsor's request that a clinical hold be removed from an investigation within 30-calendar days of the agency's receipt of the request and the sponsor's complete response to the issue(s) that led to the clinical hold. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives significant adverse comments and withdraws this direct final rule. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/10187558/Investigational_new_drug_applications DB - PRIME DP - Unbound Medicine ER -

Tags

Investigational new drug applications; clinical holds--FDA. Direct final rule.Fed Regist. 1998 Dec 14; 63(239):68676-8.FR