§ 360bbb–1. Dispute resolution

263 words·~1 min read·/usc/title-21/section-360bbb-1

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If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [ 42 U.S.C. 262 ], 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 section 355(n) of this title or an advisory committee described in section 360e(g)(2)(B) of this title .

Any such review shall take place in a timely manner. The Secretary shall promulgate such regulations within 1 year after November 21, 1997 . ( June 25, 1938, ch. 675, § 562 , as added Pub. L. 105–115, title IV, § 404 , Nov. 21, 1997 , 111 Stat. 2368 .)

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statutes-at-large

Public Law 105–115
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes

Traces to 1 document

U.S. Code

Regulation of biological products
§ 262

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Pub. L. 105-115
111 Stat. 2368
52 Stat. 1040

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§ 360bbb–1

Dispute resolution

Fed. Reg.×8

Stat.×1

U.S.C.§ 262

Pub. L.Pub. L. 105-115

Stat.111 Stat. 2368

Stat.52 Stat. 1040

Cites 4Cited by 9 across 2 sources