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Current good manufacturing practice regulation and investigational new drugs. Direct final rule.
Fed Regist. 2006 Jan 17; 71(10):2458-62.FR

Abstract

The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. 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 any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject.

Authors

Food and Drug Administration. HHS
No affiliation info available

MeSH

BenchmarkingChemistry, PharmaceuticalClinical Trials, Phase I as TopicDrug PackagingDrugs, InvestigationalGuidelines as TopicHumansInvestigational New Drug ApplicationSafetyUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16479693

Citation

Food and Drug Administration. HHS. "Current Good Manufacturing Practice Regulation and Investigational New Drugs. Direct Final Rule." Federal Register, vol. 71, no. 10, 2006, pp. 2458-62.
Food and Drug Administration. HHS. Current good manufacturing practice regulation and investigational new drugs. Direct final rule. Fed Regist. 2006;71(10):2458-62.
Food and Drug Administration. HHS. (2006). Current good manufacturing practice regulation and investigational new drugs. Direct final rule. Federal Register, 71(10), 2458-62.
Food and Drug Administration. HHS. Current Good Manufacturing Practice Regulation and Investigational New Drugs. Direct Final Rule. Fed Regist. 2006 Jan 17;71(10):2458-62. PubMed PMID: 16479693.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Current good manufacturing practice regulation and investigational new drugs. Direct final rule. A1 - ,, PY - 2006/2/17/pubmed PY - 2006/2/24/medline PY - 2006/2/17/entrez SP - 2458 EP - 62 JF - Federal register JO - Fed Regist VL - 71 IS - 10 N2 - The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. 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 any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/16479693/Current_good_manufacturing_practice_regulation_and_investigational_new_drugs__Direct_final_rule_ DB - PRIME DP - Unbound Medicine ER -