FDA updates draft facility communication guidance for pre-filing applications for priority review of generic drugs

The US FDA was released on December 2 Draft guidance entitled "ANDA: Pre-Nomination Facility Communication Related to Priority Generic Drug Submissions" was released, containing generic program enhancements related to the content, timing and evaluation of Pre-Nomination Facility Communications (PFC) in the Simplified New Drug Application (ANDA) review program, which is the Generic User Fee Amendment Reauthorization (GDUFA).
III) part
.

As early as GDUFA II, FDA agreed to reduce the review time for priority qualified generic drugs from 10 months to 8 months, but sponsors must submit two months prior to ANDA submission PFC
。 FDA can use this two-month period to determine if a facility inspection is required and, if so, to begin inspection planning
early in the review process.
According to the GDUFA III Letter of Commitment, FDA Agreed to develop performance targets and improvements
on all aspects of the generic drug review program, building on previous authorization from GDUFA.

The new draft guidance replaces the draft
guidance published in November 2017.
The revised draft guidance generally refers to the provisions of the GDUFA III Letter of Commitment and introduces the PFCs of the priority ANDA Content, timing and evaluation and recommendations so that ANDA is eligible for priority review
under the provisions of GDUFA III.
The guidelines also provide information about FDA on PFC Information
on the review process.
Specifically, the guidelines include:

The content and format of facility information to be submitted to enable FDA to evaluate facilities listed in the PFC;

PFC's timelines, and the intersection of these schedules with ANDA filing schedules;

Possible results of the FDA's review of PFC;

When and how FDA communicates
with applicants about the PFC received and the target date for designating the ANDA.

The FDA says a complete PFC submission should include all the information reviewers need to make informed decisions
about facility inspection needs to support their ANDA application.
PFC submissions should include the FDA Information required to evaluate facilities involved in drug manufacturing processes and testing, including facilities in the Class II Active Pharmaceutical Ingredient Master File (API DMF) referenced in the ANDA and participation in support of ANDA Bioavailability/bioequivalence analysis and clinical studies at all sites or organizations
.

The FDA states that "a complete and accurate PFC should provide FDA with the drug product or API to identify each facility.
" Production operation capability and necessary information
required to determine (pre-approval inspection) necessity.
This information should include a description of the production process, control of critical steps, and expected differences
between pilot/demonstration batches and commercial-scale processes.
Information should be provided that demonstrates the batch's compliance with quality standards
.
”

For each production facility, the guidelines recommend that applicants provide: facility name, operations performed, facility contact name, address, FDA Facility Identification Number (FEI), DUNS code, registration information, confirmation that the facility is ready for inspection, and confirmation that the Type II DMF all have similarly complete and accurate facility information
.

The FDA emphasizes that PFCs must be submitted in eCTD format at least 60 days before the ANDA is submitted
to the FDA for review.

The guidance states, "Generally, under the terms of the GDUFA III Commitment Letter, if the PFC is found to be incomplete or inaccurate, or at the time the ANDA is filed 10 will generally apply if there is a significant change in the information contained in the ANDA, or if the information received in the final bioequivalence study included in the ANDA results in FDA determining that the inspection is necessary months of standard review target dates, rather than priority review target dates
.
”

The draft guidance also lists facility information
that FDA would like sponsors to provide if there are clinical bioequivalence study sites and analytical bioequivalence sites.
The guide also includes a Q&A section that addresses questions about PFC
FAQs.