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21 U.S.C. 360e - Premarket approval

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Publication TitleMouse over help for Publication Title says The title of the publication. Sections within the United States Code can be searched using the title field operator. Search field operator example is title:"coral reef conservation program".United States Code, 2006 Edition, Supplement 4, Title 21 - FOOD AND DRUGS
CategoryMouse over help for Category says The category to which the collection belongs. Search field operator example is category:"bills and statutes". Bills and Statutes
CollectionMouse over help for Collection says The collection to which the document belongs. Typically the same as the publication or series. Search field operator example is collection:uscode.United States Code
SuDoc Class NumberMouse over help for SuDoc Class Number says The SuDoc class number from the U.S. Superintendent of Documents which classifies Government publications by publishing agency. Search field operator example is sudocclass:"Y 1.2/5".Y 1.2/5:
Contained WithinMouse over help for Contained Within says The document hierarchicy for a U.S. Code document. Search field operator example is title:"Flag and Seal Seat of Government and the States".Title 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
Sec. 360e - Premarket approval
ContainsMouse over help for Contains says The U.S. Code sections contained within the document. section 360e
DateMouse over help for Date says The edition of the U.S. Code. 2010
Laws in Effect as of DateMouse over help for Laws in Effect as of Date says The date by which laws were included in this edition of the U.S. Code. This edition of the U.S. Code does not include laws that went into effect after this date.January 7, 2011
Positive LawMouse over help for Positive Law says Certain titles of the Code have been enacted into positive law, and pursuant to Section 204 of Title 1 of the United States Code, the text of those titles is legal evidence of the law contained in those titles. The other titles of the Code are prima facie evidence of the laws contained in those titles.No
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90 Stat. 552
104 Stat. 4515
107 Stat. 778
111 Stat. 2334
116 Stat. 1613, 1612
118 Stat. 576
121 Stat. 921
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Table Of Contents
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Table Of Contents
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Front Matter
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Sec. 351 - Adulterated drugs and devices
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Sec. 352 - Misbranded drugs and devices
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Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products
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Sec. 353a - Pharmacy compounding
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Sec. 353b - Prereview of television advertisements
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Sec. 354 - Veterinary feed directive drugs
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Sec. 355 - New drugs
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Sec. 355-1 - Risk evaluation and mitigation strategies
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Sec. 355a - Pediatric studies of drugs
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Sec. 355b - Adverse-event reporting
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Sec. 355c - Research into pediatric uses for drugs and biological products
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Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers
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Sec. 355e - Pharmaceutical security
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Sec. 356 - Fast track products
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Sec. 356-1 - Accelerated approval of priority countermeasures
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Sec. 356a - Manufacturing changes
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Sec. 356b - Reports of postmarketing studies
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Sec. 356c - Discontinuance of life saving product
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Sec. 357 - Repealed. Pub. L. 105-115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325
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Sec. 358 - Authority to designate official names
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Sec. 359 - Nonapplicability of subchapter to cosmetics
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Sec. 360 - Registration of producers of drugs or devices
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Sec. 360a - Clinical trial guidance for antibiotic drugs
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Sec. 360b - New animal drugs
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Sec. 360c - Classification of devices intended for human use
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Sec. 360d - Performance standards
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Sec. 360e - Premarket approval
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Sec. 360e-1 - Pediatric uses of devices
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Sec. 360f - Banned devices
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Sec. 360g - Judicial review
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Sec. 360h - Notification and other remedies
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Sec. 360i - Records and reports on devices
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Sec. 360j - General provisions respecting control of devices intended for human use
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Sec. 360k - State and local requirements respecting devices
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Sec. 360l - Postmarket surveillance
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Sec. 360m - Accredited persons
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Sec. 360n - Priority review to encourage treatments for tropical diseases
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