GDUFA Review Efficiency Enhancements

LCDR Linda Park CDER Office of Generic Drugs U.S. Food and Drug Administration

Disclaimer & Disclosure

View presented are those of the speaker and do not reflect official FDA, DHHS or other government opinion or policy. I have nothing to disclose.

Learning Objectives
Complete Response (CR) Easily Correctable Deficiency (ECD) Post First Complete Response (CR) Teleconference Meeting Request

Complete Response (CR)

Complete Response (CR)

A written communication to an applicant or DMF holder describing all of the deficiencies that the Agency has identified and must be satisfactorily addressed before the ANDA can be approved Reflects division level review of deficiencies from all relevant review disciplines, including inspections Requires a Complete Response Amendment from the applicant to restart the clock One single response Requires a response within one year after the CR letter date Cover letter clearly identifies it is a response to CR and identifies the deficient disciplines
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Example: Complete Response (CR) Amendment Cover Letter

February 21, 2014 Office of Generic Drugs Food and Drug Administration Document Room, Metro Park North VII 7620 Standish Place Rockville, MD 20855

Re: RESUBMISSION 1st MINOR (TIER 1) COMPLETE RESPONSE CHEMISTRY/BIOEQUIVALENCE/CLINICAL/MICROBIOLOGY/LABELING

ANDA 123456 ABC Capsules, 10 mg

Complete Response (CR)

OGD gains control of the review process and communicates with applicant at one time instead of fragmented, individual discipline responses Streamlines communication and fosters transparency Keeps the review process moving forward during this transition time Prepares all stakeholders to meet GDUFA commitments

Easily Correctable Deficiency (ECD)

Easily Correctable Deficiency (ECD)

ANDA review efficiency enhancement within the GDUFA Commitments Letter Not defined in the GDUFA Commitments letter History and past practices Missing information, clarification, or deficiency which OGD conveys to the applicant during the review process ECDs are found and rapidly communicated to the applicant Applicant does not need to generate new data/new studies Information is readily available to be provided to OGD

Sample ECD Fax Communication to Industry

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Instructions for Industry to Respond to ECD

Applicant must provide a complete and satisfactory response submitted to the ANDA within 10 U.S. business days of the request. Applicant responds so that the reviewer may complete review. Goal is to lead to action in a predictable timeframe.
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Example: ECD Amendment Cover Letter Page

February 21, 2014 Office of Generic Drugs Food and Drug Administration Document Room, Metro Park North VII 7620 Standish Place Rockville, MD 20855

Re: EASILY CORRECTABLE DEFICIENCY LABELING

ANDA 123456 ABC Capsules, 10 mg

** if Industry follows this example then ECD response will be coded correctly**
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Post First Cycle Complete Response (CR) Teleconference Meeting Request

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Post First Cycle CR Teleconference Meeting Request

Submit a 30-minute teleconference request within 10 U.S. business days after the issuance of first-cycle CR letter. Submit to the ANDA file and title the cover page as a Post Complete Response Teleconference Meeting Request. Submit a list of specific written questions grouped by disciplines limited to the content of the CR letter.

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Post First-Cycle CR Teleconference Meeting Request

Closing out a request is defined as: Holding the teleconference Providing written responses in lieu of holding the teleconference

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Post First-Cycle CR Teleconference Meeting Request Goals

Goals for Number of Reportable Teleconferences for ANDAs:
Closing out 200 meetings in FY 2015 Closing out 250 meetings in FY 2016 Closing out 300 meetings in FY 2017

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Information to Include in the Meeting Request

1. A proposed agenda 2. A list of specific questions grouped by discipline 3. A list of all individuals with their titles and affiliations who will attend the meeting 4. A list of FDA staff, if known, or disciplines asked to participated in the requested meeting 5. Suggested dates and times (e.g. morning or afternoon) 6. Format of the meeting (teleconference or written response)
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Meeting Request Cover Page

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Post CR Teleconference Meeting Request

OGD will attempt to meet the time frames set under other CDER User Fee Program:
Post First-Cycle CR requests submitted within 10 business days: Grant or deny within 14 calendar days Respond within 30 calendar days Submitted after 10 business days or subsequent to First-Cycle CR requests: Grant or deny within 21 calendar days Respond within 75 calendar days
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Assessing Meeting Requests

Meeting Denied: the notification will be provided to the applicant with an explanation for the denial. Meeting Granted: the applicant will be notified and the Agency will schedule the teleconference or provide a written response.

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DMF: Post First-Cycle CR Teleconference Meeting Request

DMF holder may submit a written request within 10 U.S. business days after issuance of a first-cycle CR letter to the DMF file. Outline specific written questions limited to the content of the CR letter. Title the cover page as a Post Complete Response Teleconference Meeting Request. Limited to one 30 minute teleconference per DMF holder per month. A total number of teleconferences may not exceed the total number of teleconferences for ANDAs.

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Conclusion
Complete Response (CR) Easily Correctable Deficiency (ECD) Post Complete Response Teleconference Meeting Request

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Resources

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Resources

http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm385694.htm
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Thank You for Attending!

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