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December 14, 2022 Pharma Regulatory Updates
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NEW GUIDANCE: ANDA PRE-SUBMISSION FACILITY CORRESPONDENCE

The Food and Drug Administration (FDA) is issuing this revised draft guidance to
incorporate program enhancements related to the content, timing, and assessment
of a pre-submission facility correspondence (PFC) within the abbreviated new
drug application (ANDA) assessment program agreed upon by the Agency and
industry as part of the reauthorization of the Generic Drug User Fee Amendments
(GDUFA III), as described in GDUFA Reauthorization Performance Goals and Program
Enhancements, Fiscal Years 2023 through 2027 (GDUFA III22 commitment letter).
This guidance replaces the November 2017 draft guidance for industry on ANDAs:
Pre-Submission of Facility Information Related to Prioritized Generic Drug
Applications (Pre-Submission Facility Correspondence).

Background

The Generic Drug User Fee Amendments of 2012 (GDUFA I) amended the FD&C Act to
authorize FDA to assess and collect user fees to provide FDA with resources to
help ensure patients have access to quality, affordable, safe, and effective
generic drugs. GDUFA fee resources bring greater predictability and timeliness
to the review of generic drug applications. GDUFA has been reauthorized every 5
years. New enhancements to the program are designed to maximize the efficiency
and utility of each assessment cycle, with the intent of reducing the number of
assessment cycles for ANDAs and facilitating timely access to generic medicines
for American patients.

Scope

Assessment of a PFC for a priority ANDA that will be eligible for priority
review under the provisions of the GDUFA III commitment letter. This describes:

 * The content and format of the facility information that should be submitted
   to enable FDA’s assessment of facilities listed in the PFC;

 * Timeframes for the PFC, and the intersection of these timeframes with
   submission of an AND;

 * The possible outcomes of the Agency’s assessment of a PFC; and,

 * When and how the Agency communicates with an applicant about receipt of the
   PFC and
   assignment of a goal date for the ANDA.

PRE-SUBMISSION FACILITY CORRESPONDENCE – CONTENTS

A complete and accurate PFC should contain all information needed to inform
FDA’s decision regarding the need for facility inspections that support the
assessment of an ANDA. The PFC provides the information FDA needs to assess the
facilities involved in manufacturing processes and testing of the drug product,
including facilities in corresponding Type II active pharmaceutical ingredient
drug master files (API DMFs) referenced in an ANDA, and all sites or
organizations involved in bioavailability/bioequivalence analytical and clinical
studies used to support an ANDA.
FDA assesses facility information submitted in a PFC to determine earlier in the
review cycle for the subsequent application submission whether an inspection is
necessary. In order to qualify for a priority review goal, an applicant should
submit a PFC no later than 60 days prior to the date of ANDA submission. In
general, under the terms of the GDUFA III commitment letter, if the PFC is found
to be incomplete or inaccurate, or there are significant changes to information
contained in a PFC when submitted in the ANDA, or if information received in a
final bioequivalence study report included in the ANDA leads FDA to a decision
that an inspection is necessary, the 10-month standard review goal will
generally apply instead of the priority review goal. The complete and accurate
PFC must be submitted in the electronic common technical document (eCTD) format.

A. Drug Substance and Drug Product Manufacturing and Testing Facilities

Preapproval evaluations and inspections support the assessment of an ANDA by
ensuring that any facility named or referenced in support of an ANDA can perform
a proposed manufacturing operation as described in the application. FDA utilizes
a risk-based approach to assess whether a preapproval inspection (PAI) is needed
before an ANDA can be approved from a quality perspective. A complete and
accurate PFC should provide the information necessary for FDA to determine each
facility’s manufacturing operation capabilities for drug product or API and to
identify the need for a PAI. This information should include a description of
the manufacturing process, controls of critical steps, and anticipated
differences between pilot/exhibit scale and commercial scale processes.
Information regarding the conformance of exhibit batches to specifications
should be provided. For each manufacturing facility, an applicant should also
provide the following: facility name, operation(s) performed, facility contact
name, address, FDA Establishment Identifier (FEI) number (if a required
registrant or one has been assigned), DUNS number, registration information (for
required registrants), confirmation that the facility is ready for inspection,
and certification that any Type II DMF has similarly complete and accurate
facility information.

B. Clinical Bioequivalence Study Sites and Organizations

Sites or organizations that perform the clinical portions of BE studies used to
support an ANDA are subject to inspection to evaluate the overall quality of
subject safety and data integrity at the site. A complete and accurate PFC
should contain the information needed to inform FDA’s decision regarding the
need for a bioresearch monitoring inspection of these sites, including the site
name, address, and website; study numbers; a list and description of all study
investigators consistent with section 16.1.4 of the guidance ICH E3 Structure
and Content of Clinical Study Reports (July 1996); study conduct dates; and
study protocols and any available amendments.

C. Analytical Bioequivalence Sites and Organizations

Sites or organizations that perform the analytical portions of clinical
bioequivalence studies or in vitro bioequivalence studies (collectively referred
to as analytical sites), are subject to inspection to ensure that these studies
are conducted using the highest laboratory standards and in accordance with
applicable regulations. A complete and accurate PFC should contain the
information needed to inform FDA’s decision regarding the need for a bioresearch
monitoring inspection of analytical sites, including the site name, address, and
website. For those analytical studies that were initiated no later than 60 days
prior to the ANDA submission, additional recommendations are: a list of
investigator name(s); study conduct dates; and the analytical method validation,
if completed before dosing.

RECEIPT AND ASSESSMENT PROCESS FOR PRE-SUBMISSION FACILITY CORRESPONDENCE

A. Submitting the PFC through FDA’s Electronic Submissions Gateway (ESG)

1. Obtaining a Pre-Assigned ANDA Number (if applicable): For original ANDAs, the
applicant should request a pre-assigned ANDA number before submitting the PFC.
For PASs, PAS amendments, and ANDA amendments, the applicant should use the
relevant ANDA application number on the Form FDA 356h.

2. Transmitting the PFC through FDA’s ESG: The PFC must be submitted
electronically in eCTD format through the FDA ESG following the Agency’s
instructions. When transmitting the PFC through the ESG, choose “CDER” when
selecting the appropriate Center, and choose “eCTD” when selecting the
submission type. The applicant should submit the priority ANDA consistent with
the “ANDA Submission Timing”. If the applicant decides not to submit the ANDA
after submitting the PFC, FDA should be notified in writing. The notice of
decision not to submit it the ANDA should reference the submission number and be
submitted to eCTD section 1.2, Cover Letter.

3. FDA’s Assessment of the PFC: The Agency will begin assessment of the PFC upon
receipt. FDA will send a letter to the applicant to acknowledge receipt of the
PFC. FDA will assess priority status and assign the appropriate review goal date
after the ANDA is submitted.

B. ANDA Submission Timing
In order for an ANDA to be eligible to receive priority review, the PFC should
be submitted not later than 60 days prior to the submission of the ANDA itself.
This timing allows the Agency to begin assessing the facility information before
receiving the ANDA. Additionally, an ANDA should not contain any significant
changes to the information submitted in the PFC. To minimize the possibility of
significant changes to facility information between submission of the PFC and
the ANDA (and consequently loss of the priority review goal), FDA recommends
applicants submit the PFC not earlier than 90 days before submission of the
ANDA.

The applicant should submit a signed certification statement during ANDA
submission (in eCTD section 1.2) stating that the applicant has 1) made no
significant changes (as described in the GDUFA III commitment letter) to the
information contained in the PFC or 2) has made no changes except to exclude a
facility not involved in generating data for the application as described in
section 505(j)(11)(B) of the FD&C Act. Significant changes between PFC and ANDA
submission will result in assignment of the standard review goal. Such
significant changes should be made by including information regarding the
significant changes in the appropriate eCTD module with the ANDA submission.
Such significant changes should be identified in the cover letter.

FDA’s review of the ANDA, which will include an assessment and determination of
whether the ANDA meets the priority designation criteria, will be performed in
accordance with its applicable statutory and regulatory authorities and
policies, and procedures for ANDA reviews. At the time of receipt, FDA will
notify the applicant in the ANDA acknowledgement letter whether the ANDA or PAS
is subject to priority review.

NOTIFICATIONS TO THE APPLICANT

A. Pre-Submission Facility Correspondence Acknowledgement Letter

The Pre-Submission Facility Correspondence Acknowledgement Letter simply
acknowledges receipt of the PFC by the Agency. Eligibility for the priority
review goal based on the PFC is determined by FDA when an ANDA is submitted.

B. Determining Whether an ANDA Qualifies for the Priority Review Goal

After receiving the ANDA, FDA will determine the applicable goal date for the
submission. Establishing the applicable goal date for the ANDA is based on the
Agency’s priority designation determination at the time of ANDA submission;
assessment of whether the applicant submitted a complete and accurate PFC,
including confirmation that all facilities are ready for inspection; and
determination that the information submitted in the ANDA does not differ
significantly from what was submitted in the PFC. The Agency will convey the
outcome and resulting goal date in the ANDA acknowledgement letter.

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