USA – Generic drugmakers get guidance on tentative approvals, CRLs

Generic drug makers received a final and a draft guidance from the US Food and Drug Administration (FDA) on 28 September that address components of the submission process for an abbreviated new drug application (ANDA).

The draft guidance for generic drugmakers seeks to address problems created when a sponsor fails to respond to an ANDA complete response letter (CRL) within the timeframe stipulated by federal regulations.

The three choices an ANDA sponsor has on receipt of a CRL are to resubmit the ANDA with material that address the identified deficiencies; withdraw the ANDA; or ask for a hearing. “If an applicant fails to take one of these three actions within one year after issuance of a CRL, FDA may consider this failure to be a request to withdraw the ANDA unless the applicant has requested an extension of time to address all deficiencies identified in the CRL,” said FDA in announcing the availability of the guidance…