Priority Generic Drugs to Get Faster FDA Review

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In FDA’s draft guidance document, “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022”, the agency explains how sponsors can qualify for shorter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planning earlier in the review of the ANDA, enabling FDA to meet the shorter review timeframe," FDA wrote in the draft guidance document.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:

• Review and act on 90% of standard original ANDAs within ten months of the date of ANDA submission.

• Review and act on 90% of priority original ANDAs within the applicable review goal, which includes reviewing and acting on priority original ANDAs within eight months of the date of ANDA submission, if the applicant submits a PFC two months prior to the date of ANDA submission, and if the PFC is found to be complete and accurate and remains unchanged.

• Review and act on priority original ANDAs within ten months of the date of ANDA submission if the applicant does not submit a PFC two months prior to the date of ANDA submission or facility information changes, or is found to be incomplete or inaccurate.

• Review and act on 90% of standard major ANDA amendments within the applicable review goal.

• Review and act on 90% of standard and priority minor ANDA amendments within three months of the date of amendment submission.

For PASs, the agency agreed to:

• Review and act on standard PASs within six months of the date of PAS submission if pre-approval inspection is not required.

• Review and act on standard PASs within ten months of the date of PAS submission if preapproval inspection is required.

• Review and act on priority PASs within four months of the date of PAS submission if preapproval inspection is not required.

• Review and act on priority PASs within eight months of the date of PAS submission if preapproval inspection is required and the applicant submits a PFC two months prior to the date of PAS submission and if the PFC is found to be complete and accurate and remains unchanged.

• Review and act on major amendments to standard PASs within six months of the date of amendment submission if preapproval inspection is not required.

• Review and act on major amendments to standard PASs within ten months of the date of amendment submission if preapproval inspection is required.

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.