CFR
- Title 1 - General Provisions
- Title 2 - Grants and Agreements
- Title 3 - The President
- Title 4 - Accounts
- Title 5 - Administrative Personnel
- Title 6 - Domestic Security
- Title 7 - Agriculture
- Title 8 - Aliens and Nationality
- Title 9 - Animals and Animal Products
- Title 10 - Energy
- Title 11 - Federal Elections
- Title 12 - Banks and Banking
- Title 13 - Business Credit and Assistance
- Title 14 - Aeronautics and Space
- Title 15 - Commerce and Foreign Trade
- Title 16 - Commercial Practices
- Title 17 - Commodity and Securities Exchanges
- Title 18 - Conservation of Power and Water Resources
- Title 19 - Customs Duties
- Title 20 - Employees' Benefits
- Title 21 - Food and Drugs
- Title 22 - Foreign Relations
- Title 23 - Highways
- Title 24 - Housing and Urban Development
- Title 25 - Indians
- Title 26 - Internal Revenue
- Title 27 - Alcohol, Tobacco Products and Firearms
- Title 28 - Judicial Administration
- Title 29 - Labor
- Title 30 - Mineral Resources
- Title 31 - Money and Finance: Treasury
- Title 32 - National Defense
- Title 33 - Navigation and Navigable Waters
- Title 34 - Education
- Title 35 - Panama Canal
- Title 36 - Parks, Forests, and Public Property
- Title 37 - Patents, Trademarks, and Copyrights
- Title 38 - Pensions, Bonuses, and Veterans' Relief
- Title 39 - Postal Service
- Title 40 - Protection of Environment
- Title 41 - Public Contracts and Property Management
- Title 42 - Public Health
- Title 43 - Public Lands: Interior
- Title 44 - Emergency Management and Assistance
- Title 45 - Public Welfare
- Title 46 - Shipping
- Title 47 - Telecommunication
- Title 48 - Federal Acquisition Regulations System
- Title 49 - Transportation
- Title 50 - Wildlife and Fisheries
SUBPART D—FDA Action on Applications and Abbreviated Applications (§314.100 to §314.170)
- 314.100—Timeframes for reviewing applications and abbreviated applications.
- 314.101—Filing an application and receiving an abbreviated new drug application.
- 314.102—Communications between FDA and applicants.
- 314.103—Dispute resolution.
- 314.104—Drugs with potential for abuse.
- 314.105—Approval of an application and an abbreviated application.
- 314.106—Foreign data.
- 314.107—Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(j) of the act.
- 314.108—New drug product exclusivity.
- 314.110—Complete response letter to the applicant.
- 314.122—Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.
- 314.125—Refusal to approve an application.
- 314.126—Adequate and well-controlled studies.
- 314.127—Refusal to approve an abbreviated new drug application.
- 314.150—Withdrawal of approval of an application or abbreviated application.
- 314.151—Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
- 314.152—Notice of withdrawal of approval of an application or abbreviated application for a new drug.
- 314.153—Suspension of approval of an abbreviated new drug application.
- 314.160—Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
- 314.161—Determination of reasons for voluntary withdrawal of a listed drug.
- 314.162—Removal of a drug product from the list.
- 314.170—Adulteration and misbranding of an approved drug.
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