The Center for Drug Evaluation and Research (CDER) is the FDA division responsible for ensuring that human drugs are safe, effective, and properly labeled.
The approval process involves two stages. First, before CDER will permit a new drug to be tested on humans, the drug's sponsor must file an IND - a "Notice of Claimed Investigational Exemption for a New Drug." The IND contains the drug's structural formula, animal testing results, the proposed protocol for clinical testing, and other data.
After the trials, but before marketing, the manufacturer files a New Drug Application (NDA), which must contain full information about the product and clinical trial results. Each NDA is reviewed by various FDA scientists. In some instances, the NDA is also reviewed by a public advisory committee.
Except in rare circumstances, documents regarding an IND are not disclosable under the Freedom of Information Act. FDA maintains that even the acknowledgment of the existence of an IND could damage a drug sponsor's competitive position.
Once the NDA is approved, information about the approval may be released under FOIA. The basic information package relating to the approval of a New Drug Application includes:
Note: SBOAs are no longer prepared for most new drug approvals. However, the same information is released in the reviews mentioned above, although not in the same format.
When the patent and marketing exclusivity for a particular drug has expired, the drug may be manufactured by other companies as well. Manufacturers of these generic or "me-too" forms are not required to repeat the extensive preclinical and clinical testing required for new drugs. Rather, they may submit an Abbreviated New Drug Application (ANDA) documenting the bioequivalence of their formulation of the drug. The FDA reviews ANDAs to compare the generic product to the original product to ensure that comparable blood levels of active ingredients are produced. After approval, basic information about an ANDA is available:
Adverse Reaction Reports are summaries of all of the adverse experiences with specific drug products reported to FDA. Special FDA-assessed computer charges apply to procuring these documents; our information specialists can advise you as to the current availability and cost.