|
Unapproved Drugs:
Drugs Marketed in the United States That Do Not Have Required FDA Approval
Industry Information
Industry Information
The FDA wants to encourage voluntary compliance, and creates incentives for manufacturers of marketed, unapproved drugs to seek approval of their products, as this process is essential to ensuring that physicians prescribe and patients take products that are safe, effective, properly manufactured, and accurately labeled. The FDA's Center for Drug Evaluation and Research (CDER) is responsible for making certain that both prescription and OTC drugs are safe and effective. It is the responsibility of the company seeking to market a drug to submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists will review the sponsor's application containing the data and proposed labeling.
Unapproved Drug Decision Tree:
The associated decision tree  is intended to be a guide that provides an overall approach to understanding how marketed unapproved drugs may comply with requirements under the Federal Food, Drug, and Cosmetic Act. The following are ways a firm can legally market drugs:
Unapproved Drugs Coordinator
The Unapproved Drugs Coordinator in the Office of New Drugs is available to assist you in obtaining information regarding the application process and can be reached at 301-796-0700. CDER recommends that any firm marketing an unapproved drug contact the coordinator and, at the same time, schedule a meeting with the relevant review division to discuss what data would be required to support an application for approval.
Marketed Unapproved Drugs Workshop (January 9, 2007)
This workshop educated firms about the drug application and OTC monograph processes and provided firms with information on how to bring their products into compliance with approval requirements.
Required reporting of adverse events:
Manufacturers of unapproved prescription products are required to report unexpected, serious adverse events to the Agency per 21 C.F.R. 310.305. Adverse events should be reported on Form FDA 3500A . It is for use by user facilities, distributors, importers, applicants, and manufacturers for mandatory reporting of adverse events and product problems as designated in the applicable statutes and FDA regulations.
Instructions for completing Form FDA 3500A along with questions about mandatory reporting are available. To learn more about submitting reports electronically go to Introduction to AERS Electronic Submissions.
 Back
to Top 
Back to Unapproved Drugs
PDF requires the free Adobe
Acrobat Reader
Date created: September 23, 2008 |
