Postmarketing Drug Safety Evaluations

Postmarketing Drug Safety Evaluations

What is FDA Posting?
Why is FDA posting this summary information?
What information is provided on this web site?
What information does FDA consider for these postmarketing safety evaluations?
How is the information analyzed?
Postmarketing Drug Safety Evaluation Summaries

What is FDA posting?
This web site provides summary information about ongoing and completed postmarketing safety evaluations of adverse drug experience reports made to FDA for New Drug Applications (NDAs) and Biologic License Applications (BLAs) approved since September 27, 2007. The evaluations are done to determine if there are any new serious adverse events not previously identified during product development, known side effects reported in unusual number, or potential new safety concerns now that the products are being used in the general population. In accordance with Title IX, section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) which created a new section 505(r) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 355(r)), these postmarketing evaluations are performed 18 months after approval of the drug or after its use by 10,000 individuals, whichever is later.

Why is FDA posting this summary information?
FDA is posting this information in accordance with section 505(r) of the FDCA. This section of the statute directs FDA to improve the transparency of information about drugs and to provide patients and health care providers better access to information about drugs by developing a web site with specified types of drug safety information.

In response to the statutory requirement, FDA developed the Postmarket Drug Safety Information for Patients and Providers web site, which has links to a wide variety of drug safety information, including this web page.

What information is provided on this web site?
The web site includes the table below which lists the names of products, application number, approval date, approved indication, summary of evaluation findings, and actions taken and ongoing surveillance activities.

What information does FDA consider for these postmarketing safety evaluations?
FDA assesses several data sources including:

The product's pre-approval safety profile
The product's current FDA-approved label
Reports made to FDA's Adverse Event Reporting System (AERS)
Reports made to the Vaccine Adverse Event Reporting System (VAERS)
Manufacturer-submitted periodic safety reports
Medical literature
Drug utilization databases
Data from post-approval clinical trials and other studies, when applicable

How is the information analyzed?
FDA analyses for the safety evaluations include:

Data mining analysis of all adverse event reports in the AERS or VAERS databases
Review serious adverse event reports
Medication error analysis
Product utilization analysis
Risk management review
Analysis of post-approval safety data from clinical trials and other studies, when applicable
Beginning not later than 18 months after approval, scientists from CDER's Office of Surveillance and Epidemiology and Office of New Drugs jointly review the relevant data, summarize findings and, when necessary, develop a plan to further investigate potential new safety issues. For medical products regulated by the Center for Biologics Evaluation and Research, this safety review and evaluation is conducted by scientists from CBER's Office of Biostatistics and Epidemiology and the relevant product office (Office of Blood Research and Review, Office of Vaccine Research and Review, or Office of Cellular, Tissue and Gene Therapies). FDA will compile the postmarket safety evaluations and post these summaries as quarterly reports going forward.

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Postmarketing Drug Safety Evaluations