NADAs and ANADAs

Reports and records for new animal drugs

An FDA Final Rule has been published to amend the regulations for records and reports concerning experiences with approved new animal drugs, effective 30 June 2003^1,2. The Interim Rule, published on 4 February 2002, is withdrawn as of 31 March 2003³. The FDA received comments on the Interim Rule and, as a result, the Final Rule defines more clearly the kinds of information to be maintained and submitted by new animal drug applicants for new animal drug applications (NADA) or abbreviated new animal drug applications (ANADA). It also revises the timing and content of certain reports to enhance their usefulness, aiding protection of the public and animal health and reducing unnecessary recordkeeping and reporting requirements. The modifications include:

• revising the definitions of `applicant' and `serious adverse drug experience';
• changing the report requirement for summary reports of increased frequency of adverse drug effects;
• clarifying what safety and efficacy records a non-applicant versus an applicant must maintain;
• eliminating the requirements of submission of pre-publication manuscripts relating to completed clinical trials;
• changing the distributor's labeling so it conforms with what is permitted; and
• revising the section of the rule pertaining to distributor's signed statements to state that the distributor will promote the product only for use under the conditions stated in the approved labeling.

The Proposed Rule of December 1991 referred to records and reports following NADAs, ANADAs and medical feed applications (MFA), but the Interim Rule covered NADAs and ANADAs only. The Animal Drug Availability Act of 1996 (ADAA) amended the statutory provisions in the act regarding medicated feeds and eliminated MFAs.

References

1. FDA talk paper, 1 April 2003, www.fda.gov

2. Federal Register , 2003, 68 (61), 15355-15369

3. The Regulatory Affairs Journal , 2002, 13 (3), 252