How to File an IND Application

When a new drug is being considered for public use, federal law dictates additional investigations be conducted before approval. During this process, it is frequently necessary to send the prospective new drug to clinical investigators across the nation. Moving unapproved drugs across state lines is illegal, but the U.S. Food and Drug Administration (FDA) can provide an exemption to this law. The exemption is obtained by completing and receiving approval of an Investigational New Drug (IND) application. A physician or sponsor is required to file the IND, choosing one of three types of applications.

Instructions

• 1

  Access the application. Go to the FDA website and access the IND application form. This form is known as FDA 1571.

• 2

  Choose the application category and type. Select either the commercial or research category, then choose the specific type of IND. An Investigator IND application is submitted by a physician wishing to conduct the investigation of the drug and committing to supervise any dispensing of the medication. An Emergency Use IND application is used to seek approval for administering the drug only in emergency situations. The third type is a Treatment IND application, used with drugs potentially offering relief to serious or life-threatening conditions.

• 3

  List the name, address and phone number of the physician or sponsor submitting the IND application, along with the name of the proposed drug.

• 4

  Provide animal pharmacology and toxicology study information. Provide data from prior studies, such as types of testing on animals and findings. If humans have been tested, such as in foreign countries, offer details on the process and results.

• 5

  Describe the composition of the proposed drug. Offer detailed information on the manufacturing process for the drug. Submit the name of the manufacturer and the controls that the company has in place. Provide information on the manufacturer's stability and show that the company will be able to produce the drug in the mass quantity that may be needed should it be approved.

• 6

  Provide clinical protocols and investigator information. Describe the proposed clinical studies, risks involved and qualifications of the professionals who will be conducting these studies. Provide details on the consent process in place for anyone agreeing to participate in the study, as well as the name of a licensed review board that will investigate the findings.

• 7

  Submit the application. Mail the form to U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Central Document Room, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. If the application is for a therapeutic biological product, send it to the same address, but to the attention of the Therapeutic Biological Products Document Room. The application can also be submitted online from the FDA website.