There is a newer version
of
this Part
2020 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter V - Drugs and Devices
Part A - Drugs and Devices
United States Code, 2018 Edition, Supplement 2, Title 21 - FOOD AND DRUGS |
Bills and Statutes |
United States Code |
Y 1.2/5: |
Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices |
sections 351 to 360n-1 |
2020 |
January 13, 2021 |
No |
standard |
- Sec. 351 - Adulterated drugs and devices
- Sec. 352 - Misbranded drugs and devices
- Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products
- Sec. 353a - Pharmacy compounding
- Sec. 353a-1 - Enhanced communication
- Sec. 353b - Outsourcing facilities
- Sec. 353c - Prereview of television advertisements
- Sec. 353d - Process to update labeling for certain generic drugs
- Sec. 354 - Veterinary feed directive drugs
- Sec. 355 - New drugs
- Sec. 355-1 - Risk evaluation and mitigation strategies
- Sec. 355-2 - Actions for delays of generic drugs and biosimilar biological products
- Sec. 355a - Pediatric studies of drugs
- Sec. 355b - Adverse-event reporting
- Sec. 355c - Research into pediatric uses for drugs and biological products
- Sec. 355c-1 - Report
- Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
- Sec. 355e - Pharmaceutical security
- Sec. 355f - Extension of exclusivity period for new qualified infectious disease products
- Sec. 355g - Utilizing real world evidence
- Sec. 355h - Regulation of certain nonprescription drugs that are marketed without an approved drug application
- Sec. 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions
- Sec. 356-1 - Accelerated approval of priority countermeasures
- Sec. 356a - Manufacturing changes
- Sec. 356b - Reports of postmarketing studies
- Sec. 356c - Discontinuance or interruption in the production of life-saving drugs
- Sec. 356c-1 - Annual reporting on drug shortages
- Sec. 356d - Coordination; task force and strategic plan
- Sec. 356e - Drug shortage list
- Sec. 356f - Hospital repackaging of drugs in shortage
- Sec. 356g - Standards for regenerative medicine and regenerative advanced therapies
- Sec. 356h - Competitive generic therapies
- Sec. 356i - Prompt reports of marketing status
- Sec. 356j - Discontinuance or interruption in the production of medical devices
- Sec. 357 - Qualification of drug development tools
- Sec. 358 - Authority to designate official names
- Sec. 359 - Nonapplicability of subchapter to cosmetics
- Sec. 360 - Registration of producers of drugs or devices
- Sec. 360a - Clinical trial guidance for antibiotic drugs
- Sec. 360a-1 - Clinical trials
- Sec. 360a-2 - Susceptibility test interpretive criteria for microorganisms
- Sec. 360b - New animal drugs
- Sec. 360b-1 - Priority zoonotic animal drugs
- Sec. 360c - Classification of devices intended for human use
- Sec. 360c-1 - Reporting
- Sec. 360d - Performance standards
- Sec. 360e - Premarket approval
- Sec. 360e-1 - Pediatric uses of devices
- Sec. 360e-3 - Breakthrough devices
- Sec. 360f - Banned devices
- Sec. 360g - Judicial review
- Sec. 360g-1 - Agency documentation and review of significant decisions regarding devices
- Sec. 360h - Notification and other remedies
- Sec. 360h-1 - Program to improve the device recall system
- Sec. 360i - Records and reports on devices
- Sec. 360j - General provisions respecting control of devices intended for human use
- Sec. 360k - State and local requirements respecting devices
- Sec. 360l - Postmarket surveillance
- Sec. 360m - Accredited persons
- Sec. 360n - Priority review to encourage treatments for tropical diseases
- Sec. 360n-1 - Priority review for qualified infectious disease products
Disclaimer: These codes may not be the most recent version. United States may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.