NATIONAL BUREAU OF ECONOMIC RESEARCH
NATIONAL BUREAU OF ECONOMIC RESEARCH

FDA Postmarketing Requirements and Commitments (PMC)

Drug companies must submit applications to the FDA and receive approval of the applications in order to market new prescription medicines (drugs and biologics). Drug and biologic applicants can agree to or be required to by the FDA to complete postmarketing studies before or after marketing approval. The postmarketing studies can be "important in improving the prescribing and use of the product; product quality; or consistency in product manufacturing. Postmarketing studies may confirm existing data, raise or answer questions, or provide new data....A company's agreement to conduct a study is called a postmarketing commitment." More information is available in the Report to Congress Reports on Postmarketing Studies.

The FDA describes the Postmarketing Requirements and Commitments database file and provides a downloadable data file.

The FDA offers a Postmarketing Requirements and Commitments searchable database as well.

The FDA Postmarketing Requirements and Commitments data is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use.

Updates and changes.

All Source Data Files
Commitment
Source
Stata
Stata 244
SAS
CSV
Desc
UCM070783.zip
txt
dta
dta
sas7bdat
csv
desc
Pre-Stata13 had a string length limit of 244 characters.

To report problems or if you have comments or suggestions , e-mail Jean Roth at jroth@nber.org

Last Update Created by Jean Roth March 28, 2015
 
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