ANDA fax amendments

Executive Summary

Guidance for industry on ANDA amendments modified to include faxed amendments among those that would stop the agency's review clock. Under its August 1999 version of the guidance, fax and telephone amendments did not affect the Office of Generic Drugs' review process. "The issuance of major, minor and fax amendments stops the review clock while the applicant addresses deficiencies noted by OGD, but telephone amendments do not stop the clock unless the applicant does not respond within the anticipated time"