Sec. 805. SUITABILITY PETITIONS

121 words·~1 min read·/statute-compilations/comps-15234/sec-805

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

## SEC. 805 SUITABILITY PETITIONS ###

(a)In general It is the sense of Congress that the Food and Drug Administration shall meet the requirement under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal Regulations, of responding to suitability petitions within 90 days of submission. ###

(b)Report The Secretary of Health and Human Services shall include in the annual reports under section 807— ####

(1)the number of pending petitions under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)); and ####

(2)the number of such petitions pending a substantive response for more than 180 days from the date of receipt.

Connectionstraces to 1

Traces to 1 document

U.S. Code

New drugs
§ 355

Citation graph

cites case law

Sec. 805

SUITABILITY PETITIONS

U.S.C.§ 355

Cites 1Cited by 0 across 0 sources