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U.S. Code most recently checked for updates: Jan 15, 2025
All Titles
Title 21
Chapter 9
Subchapter V
Part A
§ 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
§ 353d. Process to update labeling for certain generic drugs
§ 354. Veterinary feed directive drugs
§ 355. New drugs
§ 355-1. Risk evaluation and mitigation strategies
§ 355-2. Actions for delays of generic drugs and biosimilar biological products
§ 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
§ 355h. Regulation of certain nonprescription drugs that are marketed without an approved drug application
§ 356. Expedited approval of drugs for serious or life-threatening diseases or conditions
§ 356-1. Accelerated approval of priority countermeasures
§ 356-2. Accelerated approval Council
§ 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
§ 356j. Discontinuance or interruption in the production of medical devices
§ 356k. Platform technologies
§ 356l. Advanced manufacturing technologies designation program
§ 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
§ 360b-1. Priority zoonotic 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
§ 360e-4. Predetermined change control plans for devices
§ 360f. Banned devices
§ 360g. Judicial review
§ 360g-1. Agency documentation and review of significant decisions regarding devices
§ 360g-2. Third party data transparency
§ 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
§ 360n-2. Ensuring cybersecurity of devices
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