Pharmaceutical drug approval process regarding NDA and ANDA.

1. DELIEVERED BY
MISS. JAGRUTI K. KALE
(F.Y. M.PHARM)
ROLL NO : 8
Sir .Dr. M. S. Gosavi College Of Pharmaceutical Education And
Research.
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2. 1. NEW DRUG APPLICATION (NDA)
 Introduction
 Objective
 NDA format
 Requirements for NDA
 NDA content
 NDA review
 Action letter
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3. 2. ABBREVIATED NEW DRUG APPLICATION (ANDA)
 Introduction
 Goal of ANDA
 Requirements for filling ANDA
 Steps of ANDA
 Types of ANDA
 Patent certification condition
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4.  An application submitted by the manufacturer of a drug to
the FDA- after clinical trials have been completed- for a
license to market the drug for a specified.
 New Drug Application is a regulatory mechanism that is
designed to give FDA sufficient information to make a
meaningful evaluation of a new drug.
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5.  Whether the drug`s proposed labeling (package Insert) is
appropriate, and what it should contain.
 Whether the drug is safe and effective in its proper use,
and whether the benefits of the drug outweigh the risks.
 Whether the methods used in the manufacturing the drug
and the controls used to maintain the drug`s quality are
adequate to preserve the drug`s identity, strength, quality,
and purity.
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8. A) No. of copies – before 1965- 3 copies & now only 2
copies.
 Archival copy- It contains all sections of the NDA including
cover latter, form FDA-356 h (application to market a new
drug for human use) administrative section, NDA index
and all technical sections.
It is the only copy that contains the case report tabulation
and case report form.
 Review copy – It contains a NDA technical section along
with the cover letter, form FDA-356, NDA index as well as
individual table of content, the labeling section and
application summary.
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9.  Field copy – This is required by FDA inspector during pre-
approval facilities inspections.
In the addition to the content review copy it includes the
CMC (Chemistry, manufacturing and the control) and
method validation package.
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10. 10
 Folder
-color folder
Eg. Archival red
-Name of applicant and name of drug product
-NDA no. if known copy- blue
chemistry section-
 Paper size and binding
-page 8.5 – 11 inches
Bound at left side
-Use both side
-Accurately no.

11.  Pagination
-Page no both copy should have same.
 Volume size and identification
-Not more than 2 inches thick
-Should have name of applicant, drug NDA no.
Packing carton
- Box size 14-12-9.5 inches
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16.  Usually six different teams responsible for reviewing NDA
includes :
 1)Chemistry
 2)Clinical
 3)Pharmacology/Toxicology
 4)Statistics
 5)Biopharmaceutical
 6)Microbiology
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17. AN APPROVAL
LETTER
• Signifies that all
requirements
for approval are
met.
• Company can
begin
marketing the
drug.
AN
APPROVABLE
LETTER
• Signifies that
applicant
substantially
complies with
requirements
but has some
minor
deficiencies.
• Product
sponsor must
respond within
10 days of
receipt.
A NON-
APPROVABLE
LETTER
• Signifies that
FDA has major
concern wit the
application.
• Will not
approve the
proposed drug.
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19.  Abbreviated New Drug Application (ANDA) is an
application for a license to market a generic(or a duplicate)
version of a drug that has already been granted an
approval under a full NDA(i.e. the drug has already met the
statutory standards for safety & effectiveness).
 ANDA are used when a patent has expired for a product
that has been on the U.S. market & a company wishes to
market a copy.
 It contains data which submitted to FDA`s CDER, office of
generic drugs; provides for the review & ultimate approval
of generic drugs.
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20. To reduce the price of
drug.
To reduce the time
development.
Increase the
bioavailability of the
drug in comparison to
reference list drug.
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21.  The required patent information has not been filed.
 The patent has expired.
 Not expired but will expire on particular date.
 by the drug for which ANDA applicant require
approval.
 If more than one ANDA for particular drug:
First filed ANDA is entitled to have 180 days marketing
exclusivity period followed by approval against later filled
ANDA.
 Patent is unenforceable or invalid or not be infringed
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22. • With in first 60 days –
submission, filling review is
completed.
• This group, organized under
the division of labeling &
program support(DLPS)
FILLING
REVIEW
• Applicant Project
Manager(APM) serve as co-
leader for the chemistry
review teams.
• Review application with in
180 days
COORDINATION
OF THE
GENERIC DRUG
REVIEW
PROCESS
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• BPM access list of
pending ANDA.
• ‘First in, first-
reviewed’ policy.
BIOEQUIVA
LENCE
REVIEW
PROCESS
• Organized in review
team of 6 reviewers
& a team leader.
• Tertiary review by
deputy director.
CHEMISTR
Y REVIEW
PROCESS

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• Team leader
oversees the work
of 4-6 reviewers.
• Labeling in ANDA is
“same” as RLD.
LABELLIN
G REVIEW
PROCESS
• APM communicate
with OGD
management on a
weekly basis.
• Final approval letter.
PUTTING
IT ALL
TOGETHRT

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28. As a result of Hatch-Waxman, the Food Drug and Cosmetics
Act requires that, among other things, one of the following
four certifications be made when filing an ANDA:
 The drug has not been patented.
 The patent has already expired.
 The generic drug will not go on the market until the patent
expiration
date passes.
 The patent is not infringed or is invalid.
 These certifications are referred to as the paragraphs I, II,
III, and IV certifications.
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32. To begin the FDA approval process, a generic applicant must
do two things:
 (a) certify in its ANDA that the patent in question is invalid
or is not infringed by the generic product (the “paragraph
IV certification”) and (b) notify the patent holder of the
submission of the ANDA.
 If the patent holder files an infringement suit against the
generic applicant within 45 days of the ANDA notification,
FDA approval to market the generic version is
automatically postponed for 30 months (unless, before
that time, the patent expires or is judged to be invalid or
not infringed).
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33. • An applicant can seek FDA approval to market a generic
drug before the expiration of the patent of the branded
product upon which the generic is based.
• The first company to submit a paragraph IV certification
ANDA to the FDA has the exclusive right to market the
generic drug for 180 days.
• This 180-day exclusivity period was included in the
legislation to encourage
 generic companies to invest in the required product testing
and to cover expensive legal challenges to pioneer
(innovator) products. 33

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35.  Book reference
Pisano, D.J. and Mantu, D.S., A Guide For Prescription DRUGs,
Medical Devices, AND Biologics.
Share, L. and Kinder, I. eds., 2013. Generic drug product
development: solid oral dosage forms. CRC Press.
 www.fda/cder.gov
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36.  Article references
Mossinghoff, G.J., 1999. Overview of the Hatch-Waxman Act
and its impact on the drug development process. Food &
Drug LJ, 54, p.187.
Mehl, A.B., 2006. The Hatch-Waxman Act and market
exclusivity for generic manufacturers: an entitlement or an
incentive. Chi.-Kent L. Rev., 81, p.649.
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37.  Mehl, A.B., 2006. The Hatch-Waxman Act and market
exclusivity for generic manufacturers: an entitlement or
an incentive. Chi.-Kent L. Rev., 81, p.649.
 Submissions—Content, A.N.D.A., 2014. Guidance for
Industry. Center for Biologics Evaluation and Research
(CBER).
 http://www.fda.gov/Drugs/GuidanceComplianceRegulat
oryInformation/Guidances/default.html
 Mossinghoff, G.J., 1999. Overview of the Hatc Mantus,
D. and Pisano, D.J. eds., 2014. FDA Regulatory Affairs.
CRC Press.
 h-Waxman Act and its impact on the drug development
process. Food & Drug LJ, 54, p.187.
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