PocketLaw | USC 21 | Drugs and Devices

Drugs and Devices

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Adulterated drugs and devices

Misbranded drugs and devices

Exemptions and consideration for certain drugs, devices, and biological products

Pharmacy compounding

Section
353a–1

Enhanced communication

Outsourcing facilities

Prereview of television advertisements

Veterinary feed directive drugs

New drugs

Section
355–1

Risk evaluation and mitigation strategies

Section
355–2

Actions for delays of generic drugs and biosimilar biological products

Pediatric studies of drugs

Adverse-event reporting

Research into pediatric uses for drugs and biological products

Section
355c–1

Report

Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

Pharmaceutical security

Extension of exclusivity period for new qualified infectious disease products

Utilizing real world evidence

Regulation of certain nonprescription drugs that are marketed without an approved drug application

Expedited approval of drugs for serious or life-threatening diseases or conditions

Section
356–1

Accelerated approval of priority countermeasures

Manufacturing changes

Reports of postmarketing studies

Discontinuance or interruption in the production of life-saving drugs

Section
356c–1

Annual reporting on drug shortages

Coordination; task force and strategic plan

Drug shortage list

Hospital repackaging of drugs in shortage

Standards for regenerative medicine and regenerative advanced therapies

Competitive generic therapies

Prompt reports of marketing status

Discontinuance or interruption in the production of medical devices

Qualification of drug development tools

Authority to designate official names

Nonapplicability of subchapter to cosmetics

Registration of producers of drugs or devices

Clinical trial guidance for antibiotic drugs

Section
360a–1

Clinical trials

Section
360a–2

Susceptibility test interpretive criteria for microorganisms

New animal drugs

Section
360b–1

Priority zoonotic animal drugs

Classification of devices intended for human use

Section
360c–1

Reporting

Performance standards

Premarket approval

Section
360e–1

Pediatric uses of devices

Section
360e–3

Breakthrough devices

Banned devices

Judicial review

Section
360g–1

Agency documentation and review of significant decisions regarding devices

Notification and other remedies

Section
360h–1

Program to improve the device recall system

Records and reports on devices

General provisions respecting control of devices intended for human use

State and local requirements respecting devices

Postmarket surveillance

Accredited persons

Priority review to encourage treatments for tropical diseases

Section
360n–1

Priority review for qualified infectious disease products