Fast track

products
Shivam vashisth
M pharmacy – 1st year
Drug regulatory affairs
M.D.U Rohtak
 Fast track products
A designation given by
fda to a product
 Fast track drug development
program
 It is the designation given by fda that
accelerates the approval of a new
investigational new drugs undergoing
clinical trials.
 Such status is given to agents that show
promise in treating serious life
threatening medical conditions.
 Fast Track Drug Development
Program
 Described in FDAMA of 1997, Section 506.
 Intended for new drugs to treat serious or life-
threatening diseases that can demonstrate
potential for “unmet medical needs” (e.g., no
available therapy, better tolerated, etc.).
 Multiple venues to facilitate drug development
and to expedite review of approvability:
 Frequent meetings to review development progress.
 Early review of portions of marketing application.
 Eligible for Priority Review and Accelerated Approval.
 Drugs for Life-Threatening or
Severely-Debilitating Diseases
 Procedures to expedite drug development,
evaluation, and marketing codified under 21 CFR
Part 312, Subpart E.
 Early meetings to reach agreement between FDA
and drug sponsor on necessary preclinical and
clinical studies.
 Marketing approval granted if results of adequate
and well-controlled phase 2 studies support
favorable risk-benefit analysis.
 Requirement of additional phase 4 studies.
 Criteria for fast track drug
designation
 No drug exist for the therapy..
 The therapy must demostrate an
improved effects or avoid serious
toxicities as compared to existing
drug therapy.
 Improving diagnosis of a serious
disease.
 Benefits of fast track drug
designation
 Increased communication between drug
sponser and fda.
 Eligibility for accelerated approval.

 Rolling review

 Drug gets priority review.

 Drug gets approval with in short period

of time.
 Accelerated approval process
 Surrogate end point marker-A laboratory
measurement or physical sign that is used in clinical
trials as a substitute measurement that represents a
clinically meaningful outcome such as survival or
symptom improvement.
Surrogate end point considerably shorten
the time required to receive drug approval.
Postmarketing clinial trials verify
clinical benefit
 Priority review
 A designation given to a drug
that offer major advances in
treatment or provide a
treatment where no adequate
therapy exists.
Fast track drug development
program

The sponser have to submit a request to FDA in

their IND file for gaining fast track designation
for the drug according to sec-506.
REVIEWING COMMIITTEE –

Fast track drug designation IND file is

reviewed by clinical reviewer, chief
division director and regulatory project
manager(RPM) and CBER fast track
coordinator.
Responsibilities and
procedure
Pre-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
Presubmission communication with
sponser
 Sponser should be directed to website for a copy of
guidance.
 RPM should direct the sponser to submit a fast track
request in form of documents.
 Data submitted should contain information reflecting
potential of drug to treat a serious disease.
 At sponser request FDA will discuss details
concerning a particular product and the fast track
program at IND meetings.
 Timeline for review

-CBER document control centre receives request

Request is submitted in form of 3-copies with
appropriately labelled form-1571
-RPM conducts preliminary regulatory review and
initiates routing
. RPM will indicate fast track on IND form
. After this submission is routed to clinical
reviewer and CBER fast track coordinator.
.Then documents are returned to DCC with a
priority processing slip.
 Time line for review
RPM conducts regulatory review and notifies
team-
RPM will determine wheather the request
contains information addressing each of
criteria of fast track.
If request is complete then RPM will notify all
reviewer of arrival of request by E-mail along
with target sites and the fast track check list
attachment.
 Timeline for review
 Clinical review is completed –

CBER will complete

the review and submit a completed
fast track check list to branch chief or
division director.
 Timeline for review
RPM drafts fast track letter-
RPM drafts the decision letter and E-
mails it to appropriate reviewers and the fast
track coordinator and see issues related to it.
letter finalised-
The letter is finally signed by the
appropriate office and designated in BIMS as
FAST TRACK(fast track designation granted)
 Novartis received FDA approval
for imatinib.
-To treat chronic myelogenous
leukaemia with in four months
-Kaletra received FDA approval
for the treatment of HIV/AIDS in
3.5 years.
 Steps taken by FDA towardes
accelerated
approval process
-FDA provide incentives to pharmaceutical companies
to
develope new drugs in treatment of serious diseases.
- FDA allows greatest number of patients to receive
accelerated approval drugs.
- FDA has considerably shortened the time required for
approval of the drug having fast track drug
designation.
THANK YOU FOR
YOUR
ATTENTION