- § 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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21 U.S. Code Part A - Drugs and Devices
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