Public Law 119-73 (01/23/2026)
part A Drugs and Devices
Browse units
- No subordinate units are indexed for this unit.
Sections
- § 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