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United States Code

Part A

Drugs and Devices

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