Tap any paragraph to write a margin note. Your notes collect in the Desk below the text and file under cases with @. The side-by-side margin rail opens on a larger screen.

§
Marginalia
Code · BILL · 117th Congress · H.R. 6000 (Introduced in House) — To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes. · Sec. 307

Sec. 307. Accelerating timeline for breakthrough and RMAT designations

228 words·~1 min read·/bill/117/hr/6000/ih/section-307·

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

Section 506(a)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(a)(2) ) is amended by striking A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of the Public Health Service Act and inserting A request for the designation may be made at any point before or after submission of an application for approval of the drug under section 505(b) of this Act or licensure of the drug under section 351(a)(2) of the Public Health Service Act and shall include clinical evidence, including preliminary clinical evidence from clinical trials conducted outside of the United States .
Section 506(g)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(g)(3) ) is amended by striking concurrently with, or at any time after, submission of an application for the investigation of the drug under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act and inserting at any point before or after submission of an application for approval of the drug under section 505(b) of this Act or licensure of the drug under section 351(a)(2) of the Public Health Service Act and shall include clinical evidence, including preliminary clinical evidence from clinical trials conducted outside of the United States .
Connectionstraces to 1
Citation graph
cites case law
Sec. 307
Accelerating timeline for breakthrough and RMAT designations
U.S.C.§ 356
Cites 1Cited by 0 across 0 sources
★   the supreme law of the land   ★
Don't Tread on Me
E Pluribus Unum — out of many, one

"If you don't know your rights, you don't have any."

Marginalia · a citizen's law index
A research desk, not legal advice. Always read the cited source before relying on a summary.
Questions or an issue? support@self-law.org
disclaimerMarginalia is a research index, not a law firm. Nothing on this site is legal, tax, or financial advice and no attorney–client relationship is formed by using it. Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong. Any interpretation drawn from material on this site should be validated by a licensed attorney in your jurisdiction before you act on it.