FDA will shorten the review periods for priority generic drugs by two months.
Pharmaceutical manufacturers will soon be able to enjoy shorter FDA review times for priority generic drugs, according to the agency.
In FDA’s draft guidance document, “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022”, the agency explains how sponsors can qualify for shorter review times for priority generic drugs.
The FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate Presubmission Facility Correspondence (PFC) two months ahead of their Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), or amendment.
"This critical two-month lead time provides the agency the opportunity to determine whether facility inspections will be needed, and, when they are, to initiate inspection planning earlier in the review of the ANDA, enabling FDA to meet the shorter review timeframe," FDA wrote in the draft guidance document.
The agency’s goals for 2018 through 2022 include:
For PASs, the agency agreed to:
Those who want to comment on the FDA draft guidance should submit electronic comments within 90 days of publication to: https://www.regulations.gov, or written comments to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.