United States Code (Last Updated: May 24, 2014) |
Title 21. FOOD AND DRUGS |
Chapter 9. FEDERAL FOOD, DRUG, AND COSMETIC ACT |
SubChapter V. DRUGS AND DEVICES |
Part A. Drugs and Devices |
§ 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 |
§ 354. Veterinary feed directive drugs |
§ 355. New drugs |
§ 355–1. Risk evaluation and mitigation strategies |
§ 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 |
§ 356. Expedited approval of drugs for serious or life-threatening diseases or conditions |
§ 356–1. Accelerated approval of priority countermeasures |
§ 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 |
§ 357. Repealed. Pub. L. 105–115, title I, § 125(b)(1), |
§ 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 |
§ 360b. New 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 |
§ 360f. Banned devices |
§ 360g. Judicial review |
§ 360g–1. Agency documentation and review of significant decisions regarding devices |
§ 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 |