FDA Drug Approval Packages
FDA Approval Packages [formerly known as Summary Basis of Approval Equivalents (SBA)] are U.S. government documents that contain a distillation of the information provided to the U.S. Food and Drug Administration (FDA) during the new drug or biologic approval process. Individual Approval Packages are available in Adobe Acrobat ® PDF format. To order, print the order form and return the order form to our office with a check or money order in U.S. dollars. Payment is due with all orders.
What they are and why they are important
FDA Approval Packages contain the research information on new drugs or biologics submitted to the U.S. Food and Drug Administration (FDA) by drug sponsors that has been analyzed and critiqued by experts at the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Once a new drug or biologic is approved for marketing, the FDA is required to make the Approval Package available to the public. Approval Packages were formerly referred to as Summary Basis of Approval Equivalents (SBA). Approval Packages are typically large, unwieldy documents ranging from 50 to 1500 pages. To make these documents manageable, we prepare a Table of Contents and identify the pivotal studies for each package. These are the studies the drug sponsors believe prove the efficacy and safety of their submitted drug or biologic. The abstracts of the pivotal studies are also included in the Table of Contents.
The sections included in a drug Approval Package are similar to the sections included in a New Drug Application (NDA). Examples of sections include the Medical Officer's Review, Statistical Evaluation, Pharmacology and Toxicology, Administrative Documents, Correspondence, and Memoranda. Of particular clinical interest, the Medical Officer's Review and the Statistical Evaluation sections most often contain analyses of the Phase III pivotal and supportive studies. Surprisingly, not all pivotal or supportive studies are published in the medical literature. Consequently, the drug Approval Package is sometimes the only means of obtaining information on these highly important studies. In a pilot study done within our office during the summer of 1998, we looked at 20 drugs approved in 1997 to verify the publication status of the pivotal studies identified in the drug Approval Packages or SBAs. At the time of the study, 40% of the identified pivotal studies were either unpublished or appeared in journals not indexed by MEDLINE or the Iowa Drug Information Service (IDIS) databases.
FDA Approval Packages are routinely added to the IDIS database. A subscription to the IDIS database includes access to all the drug or biologic Approval Packages in the database. Alternatively, individual Approval Packages may be purchased through our office. Approval Packages are available on CD-ROM or via email. To order, print a copy of the order form and return the completed order form to our office along with a check or money order in U.S. dollars.