Part A · Drugs and Devices

Contents (67)

Section 351Adulterated drugs and devices
Section 352Misbranded drugs and devices
Section 353Exemptions and consideration for certain drugs, devices, and biological products
Section 353aPharmacy compounding
Section 353a-1Enhanced communication
Section 353bPrereview of television advertisements
Section 353cPrereview of television advertisements
Section 353dProcess to update labeling for certain generic drugs
Section 354Veterinary feed directive drugs
Section 355New drugs
Section 355Risk evaluation and mitigation strategies
Section 355-2Actions for delays of generic drugs and biosimilar biological products
Section 355aPediatric studies of drugs
Section 355bAdverse-event reporting
Section 355cResearch into pediatric uses for drugs and biological products
Section 355c-1Report
Section 355dInternal committee for review of pediatric plans, assessments, deferrals, and waivers
Section 355ePharmaceutical security
Section 355fExtension of exclusivity period for new qualified infectious disease products
Section 355gUtilizing real world evidence
Section 355hRegulation of certain nonprescription drugs that are marketed without an approved drug application
Section 356Fast track products
Section 356Accelerated approval of priority countermeasures
Section 356-2Accelerated approval Council
Section 356aManufacturing changes
Section 356bReports of postmarketing studies
Section 356cDiscontinuance of life saving product
Section 356c-1Annual reporting on drug shortages
Section 356dCoordination; task force and strategic plan
Section 356eDrug shortage list
Section 356fHospital repackaging of drugs in shortage
Section 356gStandards for regenerative medicine and regenerative advanced therapies
Section 356hCompetitive generic therapies
Section 356iPrompt reports of marketing status
Section 356jDiscontinuance or interruption in the production of medical devices
Section 356kPlatform technologies
Section 356lAdvanced manufacturing technologies designation program
Section 357Repealed. Pub. L. 105115, title I, 125(b)(1), Nov. 21, 1997, 111 Stat. 2325
Section 358Authority to designate official names
Section 359Nonapplicability of subchapter to cosmetics
Section 360Registration of producers of drugs or devices
Section 360aClinical trial guidance for antibiotic drugs
Section 360a-1Clinical trials
Section 360a-2Susceptibility test interpretive criteria for microorganisms
Section 360bNew animal drugs
Section 360b-1Priority zoonotic animal drugs
Section 360cClassification of devices intended for human use
Section 360c-1Reporting
Section 360dPerformance standards
Section 360ePremarket approval
Section 360ePediatric uses of devices
Section 360e-3Breakthrough devices
Section 360e-4Predetermined change control plans for devices
Section 360fBanned devices
Section 360gJudicial review
Section 360g-1Agency documentation and review of significant decisions regarding devices
Section 360g-2Third party data transparency
Section 360hNotification and other remedies
Section 360h-1Program to improve the device recall system
Section 360iRecords and reports on devices
Section 360jGeneral provisions respecting control of devices intended for human use
Section 360kState and local requirements respecting devices
Section 360lPostmarket surveillance
Section 360mAccredited persons
Section 360nPriority review to encourage treatments for tropical diseases
Section 360n-1Priority review for qualified infectious disease products
Section 360n-2Ensuring cybersecurity of devices