42 U.S.C. 262section 355(n) of this titlesection 360e(g)(2)(B) of this titleIf, 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 .
June 25, 1938, ch. 675, § 562Pub. L. 105–115, title IV, § 404111 Stat. 2368(, as added , , .)
Editorial Notes
References in Text
act June 25, 1938, ch. 67552 Stat. 1040section 301 of this titleThis Act, referred to in text, is the Federal Food, Drug, and Cosmetic Act, , , which is classified generally to this chapter. For complete classification of this Act to the Code, see and Tables.
Statutory Notes and Related Subsidiaries
Effective Date
section 501 of Pub. L. 105–115section 321 of this titleSection effective 90 days after , except as otherwise provided, see , set out as an Effective Date of 1997 Amendment note under .