Part A. Drugs and Devices
- § 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