Fast track Designation: This presentation includes details of US FDA accelerated programs with detail view of Fast track approval process.

1. Submittedby :
Vanshaj Raina
M. Pharmacy1st yEAR
Roll No. 16000702005
Submittedto :
TanimaRajpal
aSst. professor

2.  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

3. 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)

4. 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.(1)
Other similar Expedited studies under FDAprogram :

5.  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 :

6. (a) Serious Condition.
(b) Potential to fulfil the unmet medical need.(3)
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.

7. (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.(2)

8. Sending a Designation submission
Receiving the Fast Track Request
FDA Review and Response
Approval

9. 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.

10. 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.

11. 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.

12. 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.(4)

13. 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.(4)

14. 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 overdose
Treatment
N22041 CYANOKIT EMD 12/5/2006 Suspected cyanide
poisoning
Here are few examples of fast track drugs (5)

15. 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.

16. References:
(1) Reichert JM, Rachon SL, Zhang BD, A decade of Fast track
programs, International Journal of Expedite programmes 2008;
7(11):1-4
(2) Chary KV, Expedited drug review process: Fast but flawed, Journal
of Pharmacology and Pharmacotherapeutics 2016; 7(2): 57-61
(3) Shulman SR, Brown JS, Fast track approval program, Journal of
Applied Science and Medical Research 2015; 5(3): 6-10
(4) Henry Wilson, Expedited programs for serious conditions-Drugs
and Biologics, a textbook of guidance for Industry 2014; 5(2): 7-9,
28-33
(5) U.S Food and Drug Administration 2006,Guidance for approval of
fast track drugs; retrieved from fda.gov