Part A - DRUGS AND DEVICES

Section 351 - Adulterated drugs and devices
Section 352 - Misbranded drugs and devices
Section 353 - Exemptions and consideration for certain drugs, devices, and biological products
Section 353a - Pharmacy compounding
Section 353a-1 - Enhanced communication
Section 353b - Outsourcing facilities
Section 353c - Prereview of television advertisements
Section 353d - Process to update labeling for certain generic drugs
Section 354 - Veterinary feed directive drugs
Section 355 - New drugs
Section 355-1 - Risk evaluation and mitigation strategies
Section 355-2 - Actions for delays of generic drugs and biosimilar biological products
Section 355a - Pediatric studies of drugs
Section 355b - Adverse-event reporting
Section 355c - Research into pediatric uses for drugs and biological products
Section 355c-1 - Report
Section 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
Section 355e - Pharmaceutical security
Section 355f - Extension of exclusivity period for new qualified infectious disease products
Section 355g - Utilizing real world evidence
Section 355h - Regulation of certain nonprescription drugs that are marketed without an approved drug application
Section 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions
Section 356-1 - Accelerated approval of priority countermeasures
Section 356-2 - Accelerated approval Council
Section 356a - Manufacturing changes
Section 356b - Reports of postmarketing studies
Section 356c - Discontinuance or interruption in the production of life-saving drugs
Section 356c-1 - Annual reporting on drug shortages
Section 356d - Coordination; task force and strategic plan
Section 356e - Drug shortage list
Section 356f - Hospital repackaging of drugs in shortage
Section 356g - Standards for regenerative medicine and regenerative advanced therapies
Section 356h - Competitive generic therapies
Section 356i - Prompt reports of marketing status
Section 356j - Discontinuance or interruption in the production of medical devices
Section 356k - Platform technologies
Section 356l - Advanced manufacturing technologies designation program
Section 357 - Qualification of drug development tools
Section 358 - Authority to designate official names
Section 359 - Nonapplicability of subchapter to cosmetics
Section 360 - Registration of producers of drugs or devices
Section 360a - Clinical trial guidance for antibiotic drugs
Section 360a-1 - Clinical trials
Section 360a-2 - Susceptibility test interpretive criteria for microorganisms
Section 360b - New animal drugs
Section 360b-1 - Priority zoonotic animal drugs
Section 360c - Classification of devices intended for human use
Section 360c-1 - Reporting
Section 360d - Performance standards
Section 360e - Premarket approval
Section 360e-1 - Pediatric uses of devices
Section 360e-3 - Breakthrough devices
Section 360e-4 - Predetermined change control plans for devices
Section 360f - Banned devices
Section 360g - Judicial review
Section 360g-1 - Agency documentation and review of significant decisions regarding devices
Section 360g-2 - Third party data transparency
Section 360h - Notification and other remedies
Section 360h-1 - Program to improve the device recall system
Section 360i - Records and reports on devices
Section 360j - General provisions respecting control of devices intended for human use
Section 360k - State and local requirements respecting devices
Section 360l - Postmarket surveillance
Section 360m - Accredited persons
Section 360n - Priority review to encourage treatments for tropical diseases
Section 360n-1 - Priority review for qualified infectious disease products
Section 360n-2 - Ensuring cybersecurity of devices