Fast Track Designation

Submitted by : Vanshaj Raina M. Pharmacy 1st yEAR Roll No. 16000702005

Submitted to : Tanima Rajpal

CONTENTS What is a fast track process.

Other similar Expedited programs of FDA

History of Fast track development process

Features of Fast track designation

Approval process of Fast track designation

Withdrawal of a drug from Fast Track designation.

Conclusion

References

FAST TRACK PROCESS

Fast Track Drug Development is a process that is designed to accelerate the development and review of drugs to treat serious conditions and fill an unmet medical need.

The purpose fast track drugs is to get important new drugs to the patient earlier.

1.BREAKTHROUGH THERAPY DESIGNATION : It is a process designed to accelerate the development and review of drugs which may show substantial improvement over the current therapy.

2.ACCLERATED APPROVAL : These regulations allow the drugs for serious conditions to get approved based on surrogate endpoint.

3.PRIORITY REVIEW DESIGNATION : A priority review designation means FDA’s goal is to take action on approval of application within six months.

Other similar Expedited studies under FDA program :

History of Fast track process

In 1997, FDA’s Modernization Act directed the FDA to create a system so that the important new drugs could reach patients even more quickly.

Thus, then Fast track program was introduced as fast track designation under section 506(b) of Food, Drug and Cosmetic Act.

Under this section, FDA may grant approval to Drug as Fast track designation if two criteria's are Fulfilled :

(a) Serious Condition.

(b) Potential to fulfil the unmet medical need. Features of Fast track

Designation(a).Expedite Development and Review : Once the FDA receives a Fast track request, early and frequently interaction with the review team is encouraged.These include meetings with FDA team including Pre-IND meetings, Design study, Dose response concerns and use of Bio markers.

(b).Rolling review : It means that the Drug company can submit the filled or completed section of its New Drug Application to FDA rather than waiting until every section of its New Drug Application gets completed.

(c).Ability to address emerging public health need : Drugs under Fast track designation can be approved or passed more quickly which may benefit the patient as the time for drug availability will be less.

(d).Showing superior effect and therapeutic action on serious and adverse outcomes.

Approval process for Fast track Designation Sending a Designation submission

Receiving the Fast Track Request

FDA Review and Response

Approval

1. Sending a Designation Submission• Sponsors may request Fast Track designation

when the INDA is first submitted or at any time thereafter before receiving marketing approval of their NDA.

• Usually, FDA should receive the Fast track request no later than pre-IND meeting with the Agency because once the meeting is over, no other features of Fast track Designation will be applied.

 • If a sponsor’s drug development program is

granted fast track designation for one indication and has subsequently obtained data to support fast track designation for another indication, the sponsor should submit a separate request.

2.Content of Designation Submission :The request should contain the following information captured in 15-20 pages and ‘REQUEST FOR FAST TRACK DESIGNATION’ should be written on cover case in Bold letters :

The name of Sponsor’s contact person and the contact details like telephone no. , address, email etc.

If applicable ,the Investigational New Drug Application number should be mentioned.

For drug products, the proprietary name and active ingredients and for Biological products, the proper name and proprietary name should be given.

The name of Division or Office to which the IND has been submitted. Summary of Information that support Fast track designation request which includes the following:

Information for considering the drug capability to address the unmet medical need. Information for considering the drug capability to treat a serious condition

3. Receiving the Fast track request :

IND and related documents are received by the Appropriate review division or by CDER.

4. FDA Response : FDA will respond to Fast track designation request within 60 days and will issue Sponsor a Designation letter or a Non-designation letter

Designation letter : If the agency is satisfied with the submission of sponsor, they may issue a designation letter.

Non-designation letter : If the agency was not satisfied with the submission of sponsor, they may issue a non designation letter. The reason may be stated as drug failed to meet the criteria for Fast track designation.

Withdrawal of Fast Track Designation Over the years of drug development, it is expected that some drugs which are granted Fast track designation will not meet the Criteria for fast track later.This may be due to reason that new and advanced drugs are discovered and the Fast track drug no longer shows a active potential to address unmet medical need.

If the sponsor recognizes that Fast track drug development program will no longer be continued, same must be informed to Agency.

The Agency then send a confirmation letter to the sponsor indicating the end of his Fast track designation.

Fast Track Approved drugs

NDA Reg. No.

Name of the Drug

Applicant

Approval Date

Therapeutic Use

N22268 COARTEM NOVARTIS 4/07/2009

Malaria treatment

N22059 TYKERB GSK 26/2/2010

Over expressing Breast Cancer

N21991 ZOLINZA MERCK 10/6/2006

T-cell lymphoma treatment

N21937 ATRIPLA GILEAD SCIENCES

7/12/2006

Treatment of HIV

N21882 EXJADE NOVARTIS 12/1/2004

Chronic Iron overdoseTreatment

N22041 CYANOKIT EMD 12/5/2006

Suspected cyanide poisoning

Here are few examples of fast track drugs :

SUMMARY Fast track designation is a process by which the drug for serious or life threatening disease can be developed more rapidly and can be easily delivered to the patients.

In order to get fast track approval, applicant sends a submission to agency along with the NDA containing all required information of the drug.FDA issues a Designation letter or Non designation letter after review and verification of details.

Many Fast track drugs are approved from time to time but they can be recalled if they show adverse effect on patients.

Also, if sponsor feels that he no longer wants to continue fast track program, he can inform it to Agency.

References:• Reichert JM, Rachon SL, Zhang BD, A decade of Fast

track programs, International Journal of Expedite programmes 2008; 7(11):1-4

• Chary KV, Expedited drug review process: Fast but flawed, Journal of Pharmacology and Pharmacotherapeutics 2016; 7(2): 57-61

• Shulman SR, Brown JS, Fast track approval program, Journal of Applied Science and Medical Research 2015; 5(3): 6-10

• Henry Wilson, Expedited programs for serious conditions-Drugs and Biologics, a textbook of guidance for Industry 2014; 5(2): 7-9, 28-33

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