4. ABBREVIATED NEW DRUG APPLICATION
(ANDA)
These are submitted to the FDA’S CDER
(Center for drug evaluation and research ) .
The office of the generic drugs (OGD) is
located within the CDER under the office of
pharmaceuticals science , to obtain approval to
market a generic drug product.
The OGD ensures the safety and efficacy of
the generic drugs by employing a review
process that is similar to the NDA process .
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5. Once approved the applicant may manufacture
and market the generic product to provide a safe,
effective and low cost alternative .
These are termed “ Abbreviated “ because they
generally need not include preclinical and clinical data
to establish safety and effectiveness .
They must scientifically demonstrate that their
product is bioequivalent to the innovator drug .
The primary difference between the generic drug
review process and NDA process is the study
requirements .
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6. For ex : an ANDA generally requires a BE study
between the generic drug product and the reference
list of drugs .
The safety and efficacy of the RLD product were
established previously through animal , clinical , BA
studies . SO , no need to repeat for ANDA.
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7. STEPS :
1) Filling Review
2) Coordination of generic drug review process
3) Bioequivalence review process
4) Chemistry review process
5) Labeling review process
6) Putting it all together
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8. FILLING REVIEW
The process begins when the applicant submits
an ANDA to OGD.
The document room staff assigns it an ANDA
number and stamps a received date on the cover
letter of ANDA .
It is sent to consumer safety technician of
review the preliminary sections of ANDA checklist .
Within first 60 days – submission , filling review
is completed . Regulatory support branch (RSB) is
responsible for this process .
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9. Once the RSB completes filling review of the ANDA
and verifies that the applicant contains all the
necessary regulatory requirements and “
Acknowledgement “ letter is issued to the applicant
indicating its acceptance for the filling and official filling
date .
The applicant is then assigned to technical
reviewers.
If the ANDA does not meet the criteria for filling , a “
refuse - to – receive “ letter is issued with a list of
deficiencies .
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10. Upon filling an ANDA the RPM ( regulatory program
manager ) forwards an established evaluation request
(EER) to the office of compliance.
Office of compliance are operating in compliance
with current good manufacturing practice (cGMP)
regulations .
Currently ANDA can be submitted electronically .
All applicant who planned to submit ANDA
electronically should consult CDER’s website for
electronic submission .
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11. COORDINATION OF THE GENERIC
DRUG REVIEW PROCESS :
Now application enters the review queue , this
means that the application is assigned to a
bioequivalence reviewer , a chemist and the
labeling reviewer.
Each chemistry team consists of a team leader
, project manager and several reviewers . The
chemistry project manager serves as a Applicant
Project manager ( APM) , they plan organize and
coordinate all the review activities for the
application that they manage .
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12. BIOEQUIVALENCE REVIEW PROCESS
Bioequivalence project manager (BPM) access list of
pending ANDA assign to each individual reviewers according
to “ first-in , first-reviewed “ policy .
The DBE’S responsibility include BE section of ANDA , Bio-
investigational applications , protocols and controlled
correspondence .
This process establishes BE between a
proposed generic drug and the RLD .
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13. CHEMISTRY REVIEW PROCESS
The chemistry , manufacturing and control
(CMC) section of the application is assigned to the
chemistry division and the team based on
therapeutic category of the drug product .
The team leader assign the application to a
reviewer on his/her team according to the first-in ,
first-reviewed policy .
The chemistry division reviews CMC section of
ANDA , drug master file , annual reports , and
controlled correspondence .
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14. LABELLING REVIEW PROCESS
Labeling section of the application is assigned to
the labeling reviewer based on the therapeutic
category of the drug product .
The labeling review branch is a part of DLPS .
The team leader oversees the work of 4-
6reviewers .
The basics of the labeling review is to ensure that
the generic drug labeling is the same as the RLD
labeling .
The labeling reviewer identifies and resolvers
concern about medication errors . 14
15. The reviewer must identify the RLD .
Next step is to find the most recently approved
labeling for the RLD .
If it is not the recently approved , it is considered
as discontinuous .
The applicant may submit four copies of draft
labeling or 12 copies of final printed labeling as the
proposed labeling .
The labeling branch supports the submission of
electronic labeling which is preferred and strongly
encouraged .
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16. PUTTING IT ALL TOGETHER
After the final office level administrative review
and individual disciplines have resolved their
deficiencies , the application will either receive a
full approval or a tentative letter .
When the review of an ANDA is completed ,
the APMs draft the app approval and circulate it
with reviews and application of occurrence .
The APMs communicate with the OGD
management on a weekly basis to update them on
the progress of reviews .
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17. A full approval letter details the condition of
approval and allows the applicant to market the
generic drug product .
A tentative approval letter is issued if there are
unexpired patents or exclusivities according to the
RDL , and delays the marketing of product .
Once the office director signs the final approval
letter , APM calls and faxes a copy of approval
letter to the applicant .
The document room staff then mails the final
approval letter to the applicant .
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