Frequently Asked Questions
- Why did Pfizer develop this post marketing commitments Web site?
- What kind of information is available on this Web site?
- Why do some post marketing commitment studies take so long to complete?
- How is this Web site different from the FDA's post marketing commitments Web site?
- Does this Web site include post marketing commitments originally made by other companies that Pfizer has acquired?
- Does Pfizer use the same post marketing commitment status definitions as the FDA?
- Does this Web site include European or other country commitments?
- How often is this Web site updated?
Answers
Why did Pfizer develop this post marketing commitments Web site?
Pfizer developed this Web site to:
- Provide timely and accurate information about Pfizer's listed U.S. post marketing commitments to the public;
- Provide education about the importance of post marketing research and processes surrounding these efforts;
- Demonstrate our commitment to continue learning about the optimal use of our medicines after approval;
- Demonstrate our commitment to operate ethically, with integrity and transparency.
What kind of information is available on this Web site?
The Web site provides information on Pfizer's listed U.S. post marketing commitments, including:
- Information on specific commitments, including information by brand and generic name, specific Pfizer company name (e.g., Pfizer company listed as the applicant), application number, U.S. approval date, due date, status, commitment type, FDA commitment number, and commitment description;
- Total listed and active Pfizer U.S. post marketing commitments, and totals by type and status;
- General educational information about the post marketing commitment study process, including post marketing commitment definition, study types, status definitions, and the study development process. Frequently asked questions and a glossary of terms are also provided. See About the Information Posted on This Web Site.
Why do some post marketing commitment studies take so long to complete?
There are many steps involved in conducting studies. A protocol must be developed, and investigators (researchers) must be trained to conduct the study. Patient enrollment may take time for some studies, such as pediatric or sub-population studies. Some studies are designed to monitor the medicine over long periods of time to better understand the long-term effects. Furthermore, some safety studies may be required for the lifetime of the medicine. For more details, see Post Marketing Commitments Study Development Process.
How is this Web site different from the FDA's post marketing commitments Web site?
This Web site provides the current status of Pfizer post marketing commitments listed on the FDA Web site and includes U.S. post marketing commitments established since August 1, 2000. Information on this Web site is believed to be correct at the time of posting. The status of post marketing commitments shown on the FDA Web site may differ from information displayed on this site, due to differences in the timing of updates made to the FDA Web site. The number of commitments on the two sites may also differ, due to the frequency of such updates and/or due to multiple reporting of single commitments on the FDA Web site.
Does this Web site include post marketing commitments originally made by other companies that Pfizer has acquired?
Yes. Pfizer and its subsidiaries are the license holders for all medicines listed on this site.
Does Pfizer use the same post marketing commitment status definitions as the FDA?
Yes. Pfizer defines status of its post marketing commitments using U.S. FDA status definitions. See Post Marketing Commitment Study Status Definitions.
Does this Web site include European or other country commitments?
At this time, this Web site includes U.S. post marketing commitments only.
How often is this Web site updated?
This Web site is updated each week.
About the Information Posted on This Web Site:
This Web site contains information about Pfizer’s U.S. pharmaceutical post marketing commitments. The post marketing commitments listed here include pre-clinical, clinical and epidemiological studies or testing agreed to by Pfizer (including its subsidiaries) and the FDA, and are used to gather additional information about the safety, efficacy, or use of approved Pfizer medicines. This Web site provides the current status of Pfizer post marketing commitments listed on the FDA Web site and includes post marketing commitments established for Pfizer medicines in the U.S. since August 1, 2000. New post marketing commitments will be listed on this Web site as they are established. Released or completed post marketing commitments will be removed from the site.
This Web site does not contain technical chemistry, manufacturing and control (CMC) commitments, or commitments for medicines where Pfizer is not the FDA license holder. Information about Pfizer’s post marketing commitments to the U.S. FDA is believed to be correct at the time that the information is posted, and is subject to change as progress is made in fulfilling the commitments.
This Web site is updated weekly. The status of post marketing commitments shown on the FDA Web site may differ from information displayed on this site, due to differences in the timing of updates made to the FDA Web site. The number of commitments on the two sites may also differ, due to the frequency of such updates and/or due to multiple reporting of single commitments on the FDA Web site.
Copyright © 2002-2008 Pfizer Inc. All rights reserved. This information is intended only for residents of the United States.
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