21 USC Part A
Drugs and Devices
through Pub. L. 116-282, except Pub. L. 116-260
§
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
§
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
§
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
§
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
§
360f
Banned devices
§
360g
Judicial review
§
360g-1
Agency documentation and review of significant decisions regarding devices
§
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
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