Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency — Guidance for Industry

On 21 December 2020 the FDA announced the availability of the final guidance for industry.

FDA is issuing this guidance to provide information pertaining to review timelines that FDA will use during the COVID-19 public health emergency for the following applicant responses to complete response (CR) letters when a facility assessment is necessary before FDA can take action on a marketing application:

  • Amendments to original and supplemental abbreviated new drug applications (ANDAs) submitted to FDA 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.
  • Resubmissions of original and supplemental new drug applications (NDAs) submitted to FDA under sections 505(b)(1) and (2) of the FD&C Act.

Specifically, the guidance explains how FDA will determine review timelines following issuance of a CR letter when a facility assessment is necessary for FDA’s regulatory decision on an original or supplemental application. This guidance applies to inspections of manufacturing facilities and also bioresearch monitoring (BIMO) program sites conducting clinical, analytical, and nonclinical studies.

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