fast track product slides

8/8/2019 Fast Track Product Slides

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Fast track productsFast track products

ShivamShivam vashisthvashisth

M pharmacyM pharmacy 11ststyearyear

Drug regulatory affairsDrug regulatory affairs

M.D.U M.D.U RohtakRohtak


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Fast track productsFast track products

A designation given byA designation given byfdafda to a productto a product


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Fast track drug developmentFast track drug development

programprogram

It is the designation given byIt is the designation given by fdafda thatthat

accelerates the approval of a newaccelerates the approval of a new

investigational new drugs undergoinginvestigational new drugs undergoingclinical trials.clinical trials.

Such status is given to agents that showSuch status is given to agents that show

promise in treating serious life threateningpromise in treating serious life threateningmedical conditions.medical conditions.


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Fast Track Drug DevelopmentFast Track Drug DevelopmentProgramProgram

Described in FDAMA of 1997, Section 506.Described in FDAMA of 1997, Section 506.

Intended for new drugs to treat serious or lifeIntended for new drugs to treat serious or life--

threatening diseases that can demonstrate potentialthreatening diseases that can demonstrate potentialfor unmet medical needs (e.g., no availablefor unmet medical needs (e.g., no availabletherapy, better tolerated, etc.).therapy, better tolerated, etc.).

Multiple venues to facilitate drug development andMultiple venues to facilitate drug development and

to expedite review of approvability:to expedite review of approvability: Frequent meetings to review development progress.Frequent meetings to review development progress.

Early review of portions of marketing application.Early review of portions of marketing application.

Eligible for Priority Review and Accelerated Approval.Eligible for Priority Review and Accelerated Approval.


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Drugs for LifeDrugs for Life--Threatening orThreatening orSeverelySeverely--Debilitating DiseasesDebilitating Diseases

Procedures to expedite drug development,Procedures to expedite drug development,evaluation, and marketing codified under 21 CFRevaluation, and marketing codified under 21 CFRPart 312, Subpart E.Part 312, Subpart E.

Early meetings to reach agreement between FDAEarly meetings to reach agreement between FDAand drug sponsor on necessary preclinical andand drug sponsor on necessary preclinical andclinical studies.clinical studies.

Marketing approval granted if results of adequateMarketing approval granted if results of adequateand welland well--controlled phase 2 studies supportcontrolled phase 2 studies supportfavorable riskfavorable risk--benefit analysis.benefit analysis.

Requirement of additional phase 4 studies.Requirement of additional phase 4 studies.


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Criteria for fast track drugCriteria for fast track drug

designationdesignationNo drug exist for the therapy..No drug exist for the therapy..

The therapy mustThe therapy must demostratedemostrate anan

improved effects or avoid seriousimproved effects or avoid serious

toxicities as compared to existingtoxicities as compared to existing

drug therapy.drug therapy. Improving diagnosis of a seriousImproving diagnosis of a serious

disease.disease.


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Benefits of fast track drugBenefits of fast track drug

designationdesignation Increased communication between drugIncreased communication between drug

sponsersponser andand fdafda..

Eligibility for accelerated approval.Eligibility for accelerated approval. Rolling reviewRolling review

Drug gets priority review.Drug gets priority review.

Drug gets approval with in short period ofDrug gets approval with in short period of

time.time.


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Accelerated approval processAccelerated approval process

Surrogate end point markerSurrogate end point marker--AA laboratorylaboratorymeasurement or physical sign that is used in clinicalmeasurement or physical sign that is used in clinicaltrials as a substitute measurement that represents atrials as a substitute measurement that represents a

clinically meaningful outcome such as survival orclinically meaningful outcome such as survival orsymptom improvement.symptom improvement.

Surrogate end point considerably shortenSurrogate end point considerably shortenthe time required to receive drug approval.the time required to receive drug approval.

Postmarketing clinial trials verifyPostmarketing clinial trials verifyclinical benefitclinical benefit


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Priority reviewPriority review

A designation given to a drugA designation given to a drug

that offer major advances inthat offer major advances in

treatment or provide atreatment or provide a

treatment where no adequatetreatment where no adequate

therapy exists.therapy exists.


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Fast track drug developmentprogram

The sponser have to submit a request to FDA intheir IND file for gaining fast track designationfor the drug according to sec-506.


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REVIEWING COMMIITTEE

Fast track drug designation IND file isreviewed by clinical reviewer, chiefdivision director and regulatory projectmanager(RPM) and CBER fast track

coordinator.


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Responsibilities andprocedurePre-submission communications with sponsers

Timeline for review-(60 days)- CBER document control centre receives request.- RPM conducts preliminary regulatory review

initiates routing.- RPM conducts regulatory review and notiifiy team.- clinical review is completed.

-RPM drafts fast track letter- letter finalised


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Presubmission communication withPresubmission communication with

sponsersponser Sponser should be directed to website for a copy ofSponser should be directed to website for a copy of

guidance.guidance.

RPM should direct the sponser to submit a fast trackRPM should direct the sponser to submit a fast track

request in form of documents.request in form of documents.

Data submitted should contain information reflectingData submitted should contain information reflecting

potential of drug to treat a serious disease.potential of drug to treat a serious disease.

At sponser request FDA will discuss detailsAt sponser request FDA will discuss detailsconcerning a particular product and the fast trackconcerning a particular product and the fast track

program at IND meetings.program at IND meetings.


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Timeline for reviewTimeline for review

--CBER document control centre receives requestCBER document control centre receives request

Request is submitted in form of 3Request is submitted in form of 3--copies withcopies withappropriately labelled formappropriately labelled form--15711571

--RPM conducts preliminary regulatory review andRPM conducts preliminary regulatory review andinitiates routinginitiates routing

. RPM will indicate fast track on IND form. RPM will indicate fast track on IND form

. After this submission is routed to clinical. After this submission is routed to clinical

reviewer and CBER fast track coordinator.reviewer and CBER fast track coordinator.

.Then documents are returned to DCC with a.Then documents are returned to DCC with apriority processing slip.priority processing slip.


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Time line for reviewTime line for review

RPM conducts regulatory review and notifiesRPM conducts regulatory review and notifiesteamteam--

RPM will determineRPM will determine wheatherwheather the requestthe requestcontains information addressing each ofcontains information addressing each ofcriteria of fast track.criteria of fast track.

If request is complete then RPM will notify allIf request is complete then RPM will notify all

reviewer of arrival of request by Ereviewer of arrival of request by E--mail alongmail alongwith target sites and the fast track check listwith target sites and the fast track check listattachment.attachment.


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Clinical review is completedClinical review is completed

CBER will completeCBER will complete

the review and submit a completed fastthe review and submit a completed fast

track check list to branch chief ortrack check list to branch chief or

division director.division director.


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RPM drafts fast track letterRPM drafts fast track letter--

RPM drafts the decision letter and ERPM drafts the decision letter and E--mailsmails

it to appropriate reviewers and the fast trackit to appropriate reviewers and the fast trackcoordinator and see issues related to it.coordinator and see issues related to it.

letter finalisedletter finalised--

The letter is finally signed by theThe letter is finally signed by theappropriate office and designated in BIMS asappropriate office and designated in BIMS as

FAST TRACK(fast track designation granted)FAST TRACK(fast track designation granted)


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Novartis received FDAapprovalNovartis received FDAapproval

forfor imatinibimatinib..-- To treat chronic To treat chronic myelogenousmyelogenous

leukaemialeukaemia with in four monthswith in four months

--KaletraKaletra received FD A approval forreceived FD A approval for

the treatment of HIV/AIDS in 3.5the treatment of HIV/AIDS in 3.5

years.years.


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Steps taken by FDASteps taken by FDA towardestowardes acceleratedaccelerated

approval processapproval process

--FDA provide incentives to pharmaceutical companies toFDA provide incentives to pharmaceutical companies to

developedevelope new drugs in treatment of serious diseases.new drugs in treatment of serious diseases.

-- FDA allows greatest number of patients to receiveFDA allows greatest number of patients to receive

accelerated approval drugs.accelerated approval drugs.

-- FDA has considerably shortened the time required forFDA has considerably shortened the time required for

approval of the drug having fast track drug designation.approval of the drug having fast track drug designation.


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THANK YOU FORTHANK YOU FOR

YOURYOUR

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