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 · CFR · Title 21 — Food and Drugs · Part 314 — Applications for FDA Approval to Market a New Drug · § 314.160

§ 314.160. Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.

55 words·~1 min read·/us/cfr/t21/s§ 314.160·

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

Upon the Food and Drug Administration's own initiative or upon request of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the Federal Register announcing the approval. [57 FR 17995, Apr. 28, 1992]
Connections2 cite this
Cited by 2 sections · top 1
Citation graph
cites case law
§ 314.160
Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
Fed. Reg.×2
Cites 0Cited by 2 across 1 source
★   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 Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong.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.