AAM Says CRL Timeline Draft Guidance Raises Questions

The Association for Accessible Medicines (AAM) says an FDA draft guidance on failure to respond to an ANDA complete response letter (CRL) within the regulatory timeframe raises some questions for which the association is seeking further clarification from the agency. The association’s comment letter says the guidance says that under the Generic Drug User Fee Amendments (GDUFA), FDA has observed a steady increase in the number of complete response letters pending with industry for more than a year.

AAM says the guidance does not differentiate between a major CRL and a minor CRL and asks for clarification on (1) whether the agency has done a trend analysis to evaluate whether there have been changes in the review process of generic drug applications post-GDUFA that may have led to deficiencies that would require more than a year for an applicant to respond and (2) whether the guidance recommendations apply equally to minor CRLs.

AAM also provided technical comments, as did Apotex.