Will ANDA goal dates be adjusted if a sponsor submits a Tier 2 unsolicited amendment in the period between FDA’s issuance of a CR letter and the sponsor’s submission of its CR response?

Yes. Review of any Tier 2 unsolicited amendments received in the period between
FDA’s issuance of a CR letter and the sponsor’s submission of its CR response will
be deferred until the CR response is received. The goal will be adjusted to 12
months from the date of submission of the eligible CR response.