If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [], there is a scientific controversy between the Secretary and a person who is a sponsor, applicant, or manufacturer and no specific provision of the Act involved, including a regulation promulgated under such Act, provides a right of review of the matter in controversy, the Secretary shall, by regulation, establish a procedure under which such sponsor, applicant, or manufacturer may request a review of such controversy, including a review by an appropriate scientific advisory panel described in or an advisory committee described in . Any such review shall take place in a timely manner. The Secretary shall promulgate such regulations within 1 year after .
Structure US Code
CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V— DRUGS AND DEVICES
Part E— General Provisions Relating to Drugs and Devices
§ 360bbb. Expanded access to unapproved therapies and diagnostics
§ 360bbb–0. Expanded access policy required for investigational drugs
§ 360bbb–0a. Investigational drugs for use by eligible patients
§ 360bbb–1. Dispute resolution
§ 360bbb–2. Classification of products
§ 360bbb–3. Authorization for medical products for use in emergencies
§ 360bbb–3a. Emergency use of medical products
§ 360bbb–3b. Products held for emergency use
§ 360bbb–3c. Expedited development and review of medical products for emergency uses
§ 360bbb–4. Countermeasure development, review, and technical assistance
§ 360bbb–4b. Medical countermeasure master files
§ 360bbb–5. Critical Path Public-Private Partnerships
§ 360bbb–5a. Emerging technology program
§ 360bbb–6. Risk communication
§ 360bbb–8a. Optimizing global clinical trials
§ 360bbb–8b. Use of clinical investigation data from outside the United States
§ 360bbb–8c. Patient participation in medical product discussion
§ 360bbb–8d. Notification, nondistribution, and recall of controlled substances