Goals Integration

Ted SherwoodDirector

Office of Regulatory Operations, OGD

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Commitment Letter Language• Section I. A. 1. Review and act on 90 percent of

standard original ANDAs within 10 months of the date of ANDA submission.

• Section I. A. 2. a. Review and act on priority original ANDAs within 8 months of the date of ANDA submission, if the applicant submits a Pre-Submission Facility Correspondence 2 months prior to the date of ANDA submission

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Commitment Letter Language (cont.)

• Section II. B. 1. FDA will issue the appropriate IR(s) and/or DRL(s) from each review discipline as soon as the discipline has completed its review, with the first IR(s) and/or DRL(s) at about the mid-point of the review.

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Commitment Letter Language (cont.)• Section III. F. As set forth in guidance issued

pursuant to Section III(A)(1), the Project Manager and other appropriate members of the FDA review team will call the applicant to provide the applicant with an update on the status of the review of their application.

a.k.a. Mid-Review-Cycle T-con

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Work Group Organization• Goals• Review Classification• Information Request/Discipline Review Letter• Mid-Review-Cycle T-cons

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What is New/Changed?• 8 month goal for priority applications with

successful Pre-submission Facility Correspondence (PFC)

• Mid-point Information Request (IR)/Discipline Review Letter (DRL)

• Mid-review-cycle t-con for ANDAs in the Pre-ANDA Program…for Complex Products

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What Does it Mean?• Shorter goals for priority original applications

where applicants put the effort into developing their products and related facilities

• More communications during the goal period

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Please Note1. The following chart applies to: Original ANDAs

received under GDUFA II (original ANDAs submitted beginning in Oct. 2017)

2. It does not apply to:a. Original ANDAs received prior to GDUFA Ib. Amendmentsc. Supplements & Supplement Amendments

Day

0/re

ceip

t

8/10

mon

ths

Mid

poin

t

+ 1

Mon

.M

CD D

RL/T

-con

GDU

FA D

ate

MRD

mee

t MCD

Filin

g De

cisio

n30

-60

days

Cons

ult I

ssua

nce

Tria

ge ODD

Endo

rsem

ent

DRD

DRD

Rev.

Phas

e 1

Rev.

Phas

e 2

Amen

dmen

t

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Review Definitions• Discipline Review Letter (DRL) – communication of at least

the primary reviewer’s thoughts on the application • Discipline Review Date (DRD) – tool for managers to use to

provide reviewers clarity on when primary reviews are needed; controlled by the discipline (a.k.a. task date)

• Mid-Review Date (MRD) – date all discipline reviews should be turned over to the discipline PMs for inclusion in the DRL; controlled by the discipline

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Review Definitions (cont.)• Mid-cycle Date (MCD) – GDUFA II mid-point plus 30 days

goal (priority ANDA 5 months & standard ANDA 6 months) for communicating the primary reviewer’s thoughts to the applicant; controlled by the Commitment Letter (RPM can adjust for unsolicited amendments)

• Mid-Review-Cycle T-con – CDER initiated t-con with the applicant to discuss review thoughts, needs, clarifications, etc.; coordinated by the RPM and conducted by the MCD; Pre-ANDA…Complex Program meeting applications only

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Review Definitions (cont.)• Owner Due Date (ODD) – date review(s) needs to be

complete to allow action letter (CR, AP, TA) issuance in advance of the GDUFA II goal; controlled by the owner: - For original - date all the discipline reviews need to be

turned over to the RPM- For cross cutting PAS – date all the discipline reviews

need to be turned over to RPM- For labeling/quality only PAS – date the labeling review

should be turned over to the Labeling PM/Quality RBPM

Day

0/re

ceip

t

8/10

mon

ths

Mid

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+ 1

Mon

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CD D

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GDU

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n30

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Cons

ult I

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Tria

ge ODD

Endo

rsem

ent

DRD

DRD

Rev.

Phas

e 1

Rev.

Phas

e 2

Amen

dmen

t

PFC

Faci

lity

Asse

ss.

Linkage to final review decision

Day

0/re

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8/10

mon

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Mid

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+ 1

Mon

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CD D

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DRD

DRD

Rev.

Phas

e 1

Rev.

Phas

e 2

Amen

dmen

t

PFC

Faci

lity

Asse

ss.

Linkage to final review decisionPre-

ANDA

Pro

gram

…

Day

0/re

ceip

t

8/10

mon

ths

Mid

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t

+ 1

Mon

.

GDU

FA D

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Cons

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DRD

DRD

Rev.

Phas

e 1

Rev.

Phas

e 2

Amen

dmen

t

PFC

Faci

lity

Asse

ss.

Linkage to final review decisionPre-

ANDA

Pro

gram

… ValuableStatusPeriod

ValuableStatusChecks

If Missed

MCD

DRL

/T-c

on

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Status Calls• Very limited value

– prior to mid-cycle date– within a month of DRL amendment receipt– within two weeks of last status call > 30 days

from goal date– within one week of last status call < 30 days

from goal date

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Status Calls (cont.)• Value added

– mid-cycle date missed (should receive warning from the RPM)

– middle of review phase 2– goal date missed (should receive warning from the

RPM)

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What is the Impact?• Increased business certainty as review times

and communications are well defined• Opportunity for applicants doing it right to

pull ahead of their competitors• Opportunity for applicants doing it right to

make minor updates, corrections, etc. & gain a one cycle approval - win for FDA & firm

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Who is Responsible?• Applicants to submit PFCs• Applicants to identify appropriate

prioritization request for ANDA, and PFC basis using MAPP 5240.3

• Applicants to submit an ANDA that is accepted• Division of Filing Review priority assessment

and goal setting

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What Will They Do?• Division of Filing Review will assess:

– ANDA warrants priority– PFC found adequate by OPQ and OTS– Facilities info unchanged in ANDA– ANDA submitted appropriate period after PFC– Formal filing assessment (unchanged)

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What Should Industry Expect?Compared to GDUFA I Commitment Letter:• Defined shorter goals for priorities with PFC• More application communications

– Even more for Pre-ANDA Program• Earlier application communications• Little need to contact Regulatory Project

Managers until near goal date

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What Can Industry Do to Assist?• Submit complete and clear PFCs and ANDAs• Keep PFC and ANDA in alignment• Clearly note in the PFC and ANDA that you are

requesting a priority goal and justify it• Clearly note in ANDA if part of Pre-ANDA Program• Provide complete, clear and quick responses to

IRs/DRLs

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Tips for Industry• Use good contractors (DMFs, etc.)• Communicate with contractors (both ways)• Know and list all facilities (Manf., Bio, Clinical)

– Recent survey showed 25% of ANDAs were related to DMFs with hidden facilities, in some cases, multiple hidden facilities

– Triggers an amendment from applicant – Amendments can impact goal dates

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Tips for Industry (cont.)• Consider the timing of changes

– Unsolicited from applicant– Unsolicited and solicited from DMF holder

• Watch for external changes (RLD, USP, etc.)• Conversion only requests for TA to final approval

should be submitted 90 days prior to the date on which an applicant seeks final approval

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Resources• Formal Meetings Between FDA and Applicants of

Complex Generic Drug Products Under GDUFA (Guidance)

• ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions (Guidance)

• Prioritization of the Review of Original ANDAs, Amendments, and Supplements (MAPP 5240.3)

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Resources (cont.)• ANDA Submissions — Content and Format of

Abbreviated New Drug Applications (Guidance)

• ANDA Submissions – Refuse-to-Receive Standards (Guidance)

• Communicating Certain Deficiencies Identified During Filing Review of ANDAs (MAPP 5220.3)

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Resources (cont.)• Filing Review of Abbreviated New Drug

Applications (MAPP 5200.14)• Information Requests and Discipline Review

Letters Under GDUFA (Guidance)

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Resources (cont.)• GDUFA Webpage: (includes videos)

https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm

• CDER Small Business & Industry Assistance (SBIA): https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/default.htm

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Resources (cont.)• CDER Guidance Webpage: (lots & more to come)

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064995.htm

• CDER MAPP Webpage: (lots & more to come) https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm

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External Contact• ANDA questions – start with your Regulatory

Project Manager (RPM)

• IR/DRL questions or delays in responding –start with your discipline PM (RBPM for OPQ/quality)

Thank you!