The law › Title 21, Food and Drugs › Chapter 9

21 U.S.C. 356b: Reports of postmarketing studies

Created in 1997 by the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115). Changed by 3 later laws. No bill we track in this Congress changes it.

1 other section of the Code cite this one, including 21 U.S.C. 331.

4 parts of federal rules cite it as their authority, written by Food and Drug Administration, Department of Health and Human Services (4).

How it got hereLaws that created or changed it, newest first

2022Consolidated Appropriations Act, 2023

2012Food and Drug Administration Safety and Innovation Act

2002Public Health Security and Bioterrorism Preparedness and Response Act of 2002

1997Food and Drug Administration Modernization Act of 1997added it

21 U.S.C. 356bReports of postmarketing studies

(a)Submission

(b)Consideration of information as public information

(c)Status of studies and reports

(d)Disclosure

(e)Notification

This CongressBills that change it or would

None we track

past change
enacted this Congress
proposed

This Congress

No bill we track in the 119th Congress changes this section.

How it got here

2022

Pub. L. 117–328 added par. (2) and redesignated former par. (2) as (3). (Consolidated Appropriations Act, 2023) Law text · (a), (3)

2012

Pub. L. 112–144 substituted "section 356(c)(2)(A) of this title" for "section 356(b)(2)(A) of this title" in two places. (Food and Drug Administration Safety and Innovation Act) Law text · (e)

2002

Pub. L. 107–188 added subsecs. (d) and (e). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (d), (e)

Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.