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21 CFR 314.126 - Adequate and well-controlled studies.


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Document in Context
   
Collapse    Title 21 - Food and Drugs
Parts 170 - 199. January 1, 2010.
Toc - Table Of Contents
Toc - Table Of Contents
Collapse    Title 21 - Food and Drugs
Parts 1 - 1499. April 1, 2010.
Toc - Table Of Contents
Collapse
Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) (Parts 1 - 1299)
Toc - Table Of Contents
Toc - Table Of Contents (Parts 314 - 314)
Section 314.100 - Timeframes for reviewing applications and abbreviated applications.
Section 314.101 - Filing an application and receiving an abbreviated new drug application.
Section 314.102 - Communications between FDA and applicants.
Section 314.103 - Dispute resolution.
Section 314.104 - Drugs with potential for abuse.
Section 314.105 - Approval of an application and an abbreviated application.
Section 314.106 - Foreign data.
Section 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...
Section 314.108 - New drug product exclusivity.
Section 314.110 - Complete response letter to the applicant.
Section 314.120 - [Reserved]
Section 314.122 - Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed...
Section 314.125 - Refusal to approve an application.
Section 314.126 - Adequate and well-controlled studies.
Section 314.127 - Refusal to approve an abbreviated new drug application.
Section 314.150 - Withdrawal of approval of an application or abbreviated application.
Section 314.151 - Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
Section 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.
Section 314.153 - Suspension of approval of an abbreviated new drug application.
Section 314.160 - Approval of an application or abbreviated application for which approval was previously refused...
Section 314.161 - Determination of reasons for voluntary withdrawal of a listed drug.
Section 314.162 - Removal of a drug product from the list.
Section 314.170 - Adulteration and misbranding of an approved drug.
Subpart F - Reserved
Parts 370-499 - Reserved