U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
  1. Regulatory Information

GUIDANCE DOCUMENT

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act November 2014

Final

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides information regarding FDA’s (or the Agency’s) current thinking on interpreting section 505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 505(q) of the FD&C Act2 governs certain citizen petitions and petitions for stay of Agency action that request that FDA take any form of action related to a pending application submitted under section 505(b)(2) or 505(j) of the FD&C Act3 or a pending application for licensure of a biological product as biosimilar or interchangeable that is submitted under section 351(k) of the Public Health Service Act (PHS Act).4


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.