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21 U.S.C. 353 - Exemptions and consideration for certain drugs, devices, and biological products


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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Sec. 357 - Repealed.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, ยง125(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