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