The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in sections 355a(f) and 355c(f) of this title. Such internal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and adolescent psychiatry or pediatric rare diseases, and other individuals designated by the Secretary.
Structure US Code
CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V— 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–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
§ 355–1. 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
§ 355e. Pharmaceutical security
§ 355f. Extension of exclusivity period for new qualified infectious disease products
§ 355g. Utilizing real world evidence
§ 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
§ 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
§ 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
§ 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–2. Susceptibility test interpretive criteria for microorganisms
§ 360b–1. Priority zoonotic animal drugs
§ 360c. Classification of devices intended for human use
§ 360e–1. Pediatric uses of devices
§ 360e–3. Breakthrough devices
§ 360e–4. Predetermined change control plans for devices
§ 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
§ 360n. Priority review to encourage treatments for tropical diseases
§ 360n–1. Priority review for qualified infectious disease products