FDA Publishes Guidance on CRLs Response Timelines during Pandemic

FDA published guidance on Dec. 21, 2020 that gives information on the agency’s review timelines for applicant responses to complete response letters (CRL) when FDA must complete a facility assessment. The guidance applies to FDA review of amendments to original and supplemental abbreviated new drug applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), resubmissions of original and supplemental biologics license applications (BLAs) submitted to FDA under sections 351(a) and (k) of the Public Health Service (PHS) Act, and resubmissions of original and supplemental new drug applications (NDAs) submitted under sections 505(b)(1) and (2) of the FD&C Act. The guidance and policy will remain in effect during the COVID-19 public health emergency.

In the guidance document, FDA explains how it will determine review timelines when a CRL is issued and a facility assessment is necessary before the agency can make a decision on an original or supplemental application. The guidance applies to manufacturing facilities and bioresearch monitoring program sites.

Timelines will not be changed for resubmissions of original applications, supplements with clinical data, and manufacturing supplements for BLAs under section 351(k) of the PHS Act,

regardless of whether FDA conducts an inspection or facility assessment. “Resubmitted manufacturing prior approval supplements will be subject to a four-month timeline. All other resubmitted applications and supplements in this category will be subject to a six-month timeline,” FDA noted in the guidance.

Resubmissions of manufacturing supplements for NDAs under sections 505(b)(1) and (2) of the FD&C Act and for BLAs under section 351(a) of the PHS Act will continue to be subject to existing user fee timelines.

Source: FDA