• § 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

• § 353d. Process to update labeling for certain generic drugs

• § 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

• § 356-2. Accelerated approval Council

• § 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

• § 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

• § 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