United States Code · Part
Part A — Drugs And Devices
21 U.S.C. pt. ptA
- § 351 Adulterated Drugs And Devices
- § 352 Misbranded Drugs And Devices
- § 353 Exemptions And Consideration For Certain Drugs, Devices, And Biological Products
- § 354 Veterinary Feed Directive Drugs
- § 355 New Drugs
- § 356 Expedited Approval Of Drugs For Serious Or Life-threatening Diseases Or Conditions
- § 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
- § 353a Pharmacy Compounding
- § 353a–1 Enhanced Communication
- § 353b Outsourcing Facilities
- § 353c Prereview Of Television Advertisements
- § 353d Process To Update Labeling For Certain Generic Drugs
- § 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
- § 355–1 Risk Evaluation And Mitigation Strategies
- § 355–2 Actions For Delays Of Generic Drugs And Biosimilar Biological Products
- § 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
- § 356–1 Accelerated Approval Of Priority Countermeasures
- § 356–2 Accelerated Approval Council
- § 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