Part A. Drugs and Devices

Index

• 21 U.S.C. § 351 Adulterated Drugs and Devices
• 21 U.S.C. § 352 Misbranded Drugs and Devices
• 21 U.S.C. § 353 Exemptions and Consideration For Certain Drugs, Devices, and Biological Products
• 21 U.S.C. § 353a Pharmacy Compounding
• 21 U.S.C. § 353a-1 Enhanced Communication
• 21 U.S.C. § 353b Outsourcing Facilities
• 21 U.S.C. § 353c Prereview of Television Advertisements
• 21 U.S.C. § 353d Process to Update Labeling For Certain Generic Drugs
• 21 U.S.C. § 354 Veterinary Feed Directive Drugs
• 21 U.S.C. § 355 New Drugs
• 21 U.S.C. § 355-1 Risk Evaluation and Mitigation Strategies
• 21 U.S.C. § 355-2 Actions For Delays of Generic Drugs and Biosimilar Biological Products
• 21 U.S.C. § 355a Pediatric Studies of Drugs
• 21 U.S.C. § 355b Adverse-Event Reporting
• 21 U.S.C. § 355c Research Into Pediatric Uses For Drugs and Biological Products
• 21 U.S.C. § 355c-1 Report
• 21 U.S.C. § 355d Internal Committee For Review of Pediatric Plans, Assessments, Deferrals, Deferral Extensions, and Waivers
• 21 U.S.C. § 355e Pharmaceutical Security
• 21 U.S.C. § 355f Extension of Exclusivity Period For New Qualified Infectious Disease Products
• 21 U.S.C. § 355g Utilizing Real World Evidence
• 21 U.S.C. § 355h Regulation of Certain Nonprescription Drugs that Are Marketed Without an Approved Drug Application
• 21 U.S.C. § 356 Expedited Approval of Drugs For Serious Or Life-Threatening Diseases Or Conditions
• 21 U.S.C. § 356-1 Accelerated Approval of Priority Countermeasures
• 21 U.S.C. § 356-2 Accelerated Approval Council
• 21 U.S.C. § 356a Manufacturing Changes
• 21 U.S.C. § 356b Reports of Postmarketing Studies
• 21 U.S.C. § 356c Discontinuance Or Interruption In the Production of Life-Saving Drugs
• 21 U.S.C. § 356c-1 Annual Reporting On Drug Shortages
• 21 U.S.C. § 356d Coordination; Task Force and Strategic Plan
• 21 U.S.C. § 356e Drug Shortage List
• 21 U.S.C. § 356f Hospital Repackaging of Drugs In Shortage
• 21 U.S.C. § 356g Standards For Regenerative Medicine and Regenerative Advanced Therapies
• 21 U.S.C. § 356h Competitive Generic Therapies
• 21 U.S.C. § 356i Prompt Reports of Marketing Status
• 21 U.S.C. § 356j Discontinuance Or Interruption In the Production of Medical Devices
• 21 U.S.C. § 356k Platform Technologies
• 21 U.S.C. § 356l Advanced Manufacturing Technologies Designation Program
• 21 U.S.C. § 357 Qualification of Drug Development Tools
• 21 U.S.C. § 358 Authority to Designate Official Names
• 21 U.S.C. § 359 Nonapplicability of Subchapter to Cosmetics
• 21 U.S.C. § 360 Registration of Producers of Drugs Or Devices
• 21 U.S.C. § 360a Clinical Trial Guidance For Antibiotic Drugs
• 21 U.S.C. § 360a-1 Clinical Trials
• 21 U.S.C. § 360a-2 Susceptibility Test Interpretive Criteria For Microorganisms
• 21 U.S.C. § 360b New Animal Drugs
• 21 U.S.C. § 360b-1 Priority Zoonotic Animal Drugs
• 21 U.S.C. § 360c Classification of Devices Intended For Human Use
• 21 U.S.C. § 360c-1 Reporting
• 21 U.S.C. § 360d Performance Standards
• 21 U.S.C. § 360e Premarket Approval
• 21 U.S.C. § 360e-1 Pediatric Uses of Devices
• 21 U.S.C. § 360e-3 Breakthrough Devices
• 21 U.S.C. § 360e-4 Predetermined Change Control Plans For Devices
• 21 U.S.C. § 360f Banned Devices
• 21 U.S.C. § 360g Judicial Review
• 21 U.S.C. § 360g-1 Agency Documentation and Review of Significant Decisions Regarding Devices
• 21 U.S.C. § 360g-2 Third Party Data Transparency
• 21 U.S.C. § 360h Notification and Other Remedies
• 21 U.S.C. § 360h-1 Program to Improve the Device Recall System
• 21 U.S.C. § 360i Records and Reports On Devices
• 21 U.S.C. § 360j General Provisions Respecting Control of Devices Intended For Human Use
• 21 U.S.C. § 360k State and Local Requirements Respecting Devices
• 21 U.S.C. § 360l Postmarket Surveillance
• 21 U.S.C. § 360m Accredited Persons
• 21 U.S.C. § 360n Priority Review to Encourage Treatments For Tropical Diseases
• 21 U.S.C. § 360n-1 Priority Review For Qualified Infectious Disease Products
• 21 U.S.C. § 360n-2 Ensuring Cybersecurity of Devices