FDA Authorized Generics Reporting Requirements
On September 29, 2008, the Food and Drug Administration (FDA) published a direct final rule requiring holders of a new drug application (NDA) to submit certain information regarding authorized generic drugs in an annual report . The rulemaking is part of the agency’s implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly. The agency is publishing the requirement as a direct final rulemaking because it does not expect significant adverse comment on the rule. As part of the administrative requirements for a direct final rule, the agency is concurrently issuing a proposed rule and soliciting comments and, if any significant adverse comment is received, the FDA will withdraw the direct final rule and address the comments in a subsequent rulemaking. If there is no significant adverse comment, the direct final rule will automatically become effective February 11, 2009. Comments will be accepted until December 15, 2008, although comments on related information collection provisions are due October 29, 2008.
