Drug Application and Approval Process - "Questions and Answers"

Submit a question using the link provided below, and your question/answer may be added to this list. (Responses will also be sent to you directly.)

How do I report adverse events associated with the use of a drug?
FDA’s MedWatch Web site provides various means for voluntary reporting of serious postmarketing adverse events, product quality problems, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug or biologic. Mandatory reporting of serious adverse events associated with the use of an investigational drug or biologic, being used in a clinical trial or study conducted under a US IND, should be reported using Form FDA 3500A and submitted under the IND as described in 21 CFR 312.32. Additional information is available on the MedWatch Web site.
Which review division in OND should I contact to discuss drug development plans?
You should contact the OND review division responsible for reviewing drugs that belong to a therapeutic area (e.g., hypertension). See OND Contact Information (PDF - 22KB) ² and the specific therapeutic areas and contact information in each review division.
Where do I submit an investigational new drug application (IND), new drug application (NDA), or biologics license application (BLA)?
All regulatory submissions should be submitted to the attention of the responsible OND review division (see also #2 above) as follows:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of XXXX Products
5901-B Ammendale Road
Beltsville, MD 20705-1266

"How do I find out the marketing status of a drug?
Public information about approved drugs can be found on FDA’s Drugs@FDA Web page. Some information about unapproved products, including the results of completed trials (see also clinical trials below), is made available by the sponsors of these trials on the National Institutes for Health’s Clinicaltrials.gov² Web page. However, information submitted by a drug sponsor regarding investigational drugs that are currently under development is considered to be confidential commercial or business information, and it is not generally available to the public.

Where can I find information about ongoing clinical trials?
Clinicaltrials.gov² is an online registry of federally and privately supported clinical trials conducted in the United States and around the world. Clinicaltrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers.

Where can I find information regarding the use of drugs in children?
Information regarding the use of drugs in children and FDA initiatives aimed to improve medical product research in children can be found on the Pediatric Drug Development Web page.

Which biologic products are regulated and reviewed by CDER?
Beginning October 1, 2002, the following biologic products were transferred to CDER:

Monocolonal antibodies for in vivo use

Proteins intended for therapeutic use, including cytokines, enzymes, and other novel proteins

Immunomodulators

Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease, or otherwise alter the production of hematopoietic cells in vivo

Where can I find information regarding over-the-counter products?
CDER’s Office of Nonprescription Products (ONP) is responsible for the review and oversight of over-the-counter products. More information is available on ONP’s Web page.

Where can I find information regarding generic drug products?
CDER’s Office of Generic Drugs (OGD) is responsible for the review and oversight of generic products. More information on the use of generic drugs is available on the OGD Web page.

Where can I find information regarding dietary supplements?
Information regarding dietary supplements can be found on this Web page.

Where can I find information about product recalls?
Current information regarding significant product actions can be found on the Recalls, Market Withdrawals, & Safety Alerts Web page.

Where can I find information regarding drug imports, including the personal importation of unapproved drugs?
Information regarding drug imports, including the personal importation of unapproved drugs can be found in the Drug Import Web site.

For information on other topics, see also Resources for you link

ResourcesForYou

Office of New Drugs