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U.S. Code
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TITLE 21 - FOOD AND DRUGS
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CHAPTER 9—FEDERAL FOOD, DRU...
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SUBCHAPTER V—DRUGS AND DEVI...
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Part A—Drugs and Devices (§§ 351 – 360n–1)
Part A—Drugs and Devices (§§ 351 – 360n–1)
§ 351. Adulterated drugs and devices
§ 352. Misbranded drugs and devices
§ 353. Exemptions and consideration for certain drugs, devices, and biological products
§ 353a. Pharmacy compounding
§ 353a–1. Enhanced communication
§ 353b. Outsourcing facilities
§ 353c. Prereview of television advertisements
§ 354. Veterinary feed directive drugs
§ 355. New drugs
§ 355–1. Risk evaluation and mitigation strategies
§ 355a. Pediatric studies of drugs
§ 355b. Adverse-event reporting
§ 355c. Research into pediatric uses for drugs and biological products
§ 355c–1. Report
§ 355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
§ 355e. Pharmaceutical security
§ 355f. Extension of exclusivity period for new qualified infectious disease products
§ 355g. Utilizing real world evidence
§ 356. Expedited approval of drugs for serious or life-threatening diseases or conditions
§ 356–1. Accelerated approval of priority countermeasures
§ 356a. Manufacturing changes
§ 356b. Reports of postmarketing studies
§ 356c. Discontinuance or interruption in the production of life-saving drugs
§ 356c–1. Annual reporting on drug shortages
§ 356d. Coordination; task force and strategic plan
§ 356e. Drug shortage list
§ 356f. Hospital repackaging of drugs in shortage
§ 356g. Standards for regenerative medicine and regenerative advanced therapies
§ 356h. Competitive generic therapies
§ 356i. Prompt reports of marketing status
§ 357. Qualification of drug development tools
§ 358. Authority to designate official names
§ 359. Nonapplicability of subchapter to cosmetics
§ 360. Registration of producers of drugs or devices
§ 360a. Clinical trial guidance for antibiotic drugs
§ 360a–1. Clinical trials
§ 360a–2. Susceptibility test interpretive criteria for microorganisms
§ 360b. New animal drugs
§ 360c. Classification of devices intended for human use
§ 360c–1. Reporting
§ 360d. Performance standards
§ 360e. Premarket approval
§ 360e–1. Pediatric uses of devices
§ 360e–3. Breakthrough devices
§ 360f. Banned devices
§ 360g. Judicial review
§ 360g–1. Agency documentation and review of significant decisions regarding devices
§ 360h. Notification and other remedies
§ 360h–1. Program to improve the device recall system
§ 360i. Records and reports on devices
§ 360j. General provisions respecting control of devices intended for human use
§ 360k. State and local requirements respecting devices
§ 360l. Postmarket surveillance
§ 360m. Accredited persons
§ 360n. Priority review to encourage treatments for tropical diseases
§ 360n–1. Priority review for qualified infectious disease products