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21 CFR 314.126 - Adequate and well-controlled studies.


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Document in Context
   
Expand    Title 1 - General Provisions
Parts 1 - 500. January 1, 2010.
Collapse    Title 2 - Grants and Agreements
Parts 1 - 3700. January 1, 2010.
Expand    Title 3 - The President
Parts 100 - 102. January 1, 2010.
Expand    Title 4 - Accounts
Parts 2 - 202. January 1, 2010.
Expand    Title 5 - Administrative Personnel
Parts 1 - 9901. January 1, 2010.
Expand    Title 6 - Domestic Security
Parts 5 - 37. January 1, 2010.
Expand    Title 7 - Agriculture
Parts 1 - 4290. January 1, 2010.
Expand    Title 8 - Aliens and Nationality
Parts 1 - 1337. January 1, 2010.
Expand    Title 9 - Animals and Animal Products
Parts 1 - 592. January 1, 2010.
Expand    Title 10 - Energy
Parts 1 - 1800. January 1, 2010.
Expand    Title 11 - Federal Elections
Parts 1 - 9430. January 1, 2010.
Expand    Title 12 - Banks and Banking
Parts 1 - 1815. January 1, 2010.
Expand    Title 14 - Aeronautics and Space
Parts 1 - 1310. January 1, 2010.
Expand    Title 15 - Commerce and Foreign Trade
Parts 0 - 2301. January 1, 2010.
Expand    Title 16 - Commercial Practices
Parts 0 - 1750. January 1, 2010.
Expand    Title 17 - Commodity and Securities Exchanges
Parts 1 - 450. April 1, 2010.
Expand    Title 18 - Conservation of Power and Water Resources
Parts 1 - 1317. April 1, 2010.
Expand    Title 19 - Customs Duties
Parts 0 - 360. April 1, 2010.
Expand    Title 20 - Employees' Benefits
Parts 1 - 1010. April 1, 2010.
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
Expand
Subchapter B - FOOD FOR HUMAN CONSUMPTION (CONTINUED) (Parts 100 - 199)
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
Expand    Title 22 - Foreign Relations
Parts 1 - 1701. April 1, 2010.
Expand    Title 23 - Highways
Parts 1 - 1399. April 1, 2010.
Expand    Title 24 - Housing and Urban Development
Parts 0 - 4100. April 1, 2010.
Expand    Title 25 - Indians
Parts 1 - 1200. April 1, 2010.
Expand    Title 26 - Internal Revenue
Parts 1 - 801. April 1, 2010.
Expand    Title 27 - Alcohol, Tobacco Products and Firearms
Parts 1 - 646. April 1, 2010.
Expand    Title 28 - Judicial Administration
Parts 0 - 1100. July 1, 2010.
Expand    Title 29 - Labor
Parts 0 - 4907. July 1, 2010.
Expand    Title 30 - Mineral Resources
Parts 1 - 955. July 1, 2010.
Expand    Title 31 - Money and Finance: Treasury
Parts 0 - 904. July 1, 2010.
Expand    Title 32 - National Defense
Parts 1 - 2800. July 1, 2010.
Expand    Title 33 - Navigation and Navigable Waters
Parts 1 - 499. July 1, 2010.
Expand    Title 34 - Education
Parts 1 - 1200. July 1, 2010.
Expand    Title 36 - Parks, Forests, and Public Property
Parts 1 - 1600. July 1, 2010.
Expand    Title 38 - Pensions, Bonuses, and Veterans' Relief
Parts 0 - 200. July 1, 2010.
Expand    Title 39 - Postal Service
Parts 1 - 3060. July 1, 2010.
Expand    Title 40 - Protection of Environment
Parts 1 - 1700. July 1, 2010.
Expand    Title 41 - Public Contracts and Property Management
Parts 50 - 304. July 1, 2010.
Expand    Title 42 - Public Health
Parts 1 - 1008. October 1, 2010.
Expand    Title 43 - Public Lands: Interior
Parts 1 - 10010. October 1, 2010.
Expand    Title 45 - Public Welfare
Parts 1 - 2555. October 1, 2010.
Expand    Title 46 - Shipping
Parts 1 - 565. October 1, 2010.
Expand    Title 47 - Telecommunication
Parts 0 - 400. October 1, 2010.
Expand    Title 48 - Federal Acquisition Regulations System
Parts 1 - 9905. October 1, 2010.
Expand    Title 49 - Transportation
Parts 1 - 1580. October 1, 2010.
Expand    Title 50 - Wildlife and Fisheries
Parts 1 - 697. October 1, 2010.