Usfda generic drug user fee act a complete review

Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131

ISSN:2249-5347
IJSID
International Journal of Science Innovations and Discoveries An International peer
Review Journal for Science

Research Article Available online through www.ijsidonline.info

USFDA-GENERIC DRUG USER FEE ACT: A COMPLETE REVIEW

Dept. of Chemistry, Sri Krishnadevaraya University, Anantapur, AP, India
Useni Reddy Mallu* and Anand K

Received: 19-08-2012 ABSTRACT

USFDA has implemented several types user fee acts for human and animal
Accepted: 18-10-2012

medicines, bio-Similar, colors, exports, tobacco and medical devices. After several
discussion and negotiations with Generic Pharmaceutical Association (GPhA), USFDA has
*Corresponding Author

recently implemented Generic Drug User Fee Act (GDUFA) for Generic Drugs. GDUFA key
goals are Safety, Efficacy and Access. From the GDUFA implementation, USFDA will get the
funds approx. $1.5billion over the 2013 to 2017 financial years from the generic players.
The main intention to implement the user fee is to increase the number of reviewers in
USFDA team, speed up the facility inspections and approval process of all types of
applications including the prioritization of the paragraph-IV.
Address:

Keywords: USFDA, Generic Drug User Fee Act (GDUFA) amendments 2012, Drug Master
Name:

File (DMF), ANDA, and GDUFA cover sheet.
Dr. Useni Reddy Mallu
Place:
INTRODUCTION
Sri Krishnadevaraya University
Anantapur, AP, India.
E-mail:
drusenireddymallu@gmail.com

INTRODUCTION

International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012

117


Scope: This article is intended to provide basic information and general pathway required to adopt during filling of ANDA by
INTRODUCTION

the generic industries.
Purpose: The purpose of this article is
Educate readers on basics of the GUDFA
Enable readers to understand the difference between traditional ANDA and GUDFA adopted ANDA filling.


Summarize a wide documents related to GUDFA published by public USFDA cder domain website.



FDA has User Fee programs (UFP) to fulfill its mission of protecting the public health and accelerating innovation in
Background:

the industry. The collected fees are used to provide the safety and effective medicines to the patients. FDA has user fees for
human and animal drugs, medical and mammography devices, color additives, exports and tobacco products. The Division of
User Fees (DUF) is responsible for the overall management of the program, Office of Financial Management (OFM). The OFM
has collecting the user fee from manufacturer.
USFDA has implemented about thirteen user fee acts for protecting health and providing safety, efficacy medicines for
humans and animals. The lists of user fee acts are represented below.
1. Animal Drug User Fee Act (ADUFA)
2. Animal Generic Drug User Fee Act (AGDUFA)
3. Bio similar User Fee Act (BsUFA)
4. Color Certification (CERTS)
5. Exports Certificate (Exports)
6. Family Smoking Prevention and Tobacco Control Act (Tobacco)
7. Food Safety Modernization Act (FSMA)
8. Freedom of Information Act Fees
9. Generic Drug User Fee Act (GDUFA)
10. Mammography Quality Standards Act (MQSA)
11. Medical Device User Fee and Modernization Act (MDUFMA)
12. Prescription Drug User Fee Act (PDUFA)
13. Tobacco Product Fees

Pharmaceutical industry has grown rapidly by submitting the number of DMFs and ANDAs. FDA has the more backlog
GENERIC DRUG USER FEE ACT (GDUFA)

of Type-II DMF, ANDA applications and inspections (domestic and foreign). In the year 2010, FDA has initiated the discussions
with Generic Pharmaceutical Association (GPhA) and finally the USFDA has implemented the user fee for generic drugs
through GDUFA amendments 2012. Figure-1 to 5 represents increasing the Type-II DMFs and ANDAs application submissions,
backlog details and inspections in the last 10 years (The below figures are copied from the public FDA websites).


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Figure-1: Continued growth in the ANDA submissions in the last ten years.

Figure-2: Type-II DMF submissions for USFDA approval in the last ten years.


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Figure-3: Pending ANDAs at USFDA in the last six years.

Figure-4: FDF inspections in the last ten years.

2010: Initiation of USFDA discussions.
Origin of GDUFA:

2011: FDA has conducted the meetings with GPhA for negotiations and Implementing, drafting the GDUFA.
2012: On July 9, 2012, GDUFA was signed into law by the President. GDUFA draft Guidelines released on Sep-2012.


120


Figure-5: API facilities inspections by USFDA in the last ten years.

The purpose of GDUFA is to provide additional funds to USFDA to supplement the traditional annual funding
Why GDUFA is required?

appropriated by Congress. User fee for generic drugs provides the funding to achieve the same surveillance inspection
frequency for both domestic and foreign manufacturers to insure that all industry participants in the U.S. generic drug system
are held to consistent good manufacturing practice (GMP) standards. The three strong scopes of GDUFA are:

Figure-6: GDUFA Key Goals
Safety: Ensure that industry participants, foreign or domestic, who participate in the U.S. generic drug system are held
to consistent high quality standards and are inspected biennially, using a risk-based approach, with foreign and domestic
parity.
Access: Expedite the availability of low cost, high quality generic drugs by bringing greater predictability to the review
times for ANDAs, amendments and supplements.


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Transparency: Enhance FDA’s ability to protect Americans in the complex global supply environment by requiring the
identification of facilities involved in the manufacture of generic drugs, active pharmaceutical ingredients, and improving
FDA’s communications and feedback with industry in order to expedite product access.

USFDA have a proposal for increasing the facility inspections, speed up the review process, increasing the data base
GDUFA Goals:

management, immediate response letters to the applicant and special focus on paragraph-IV submissions. The main goals of
GDUFA are,
Backlog API DMF and ANDAs review
Speed up the review process for all submissions


Increase the facility inspections (Domestic and Foreign)


Increase the Regulatory Research


Prioritization of Paragraph-IV submission


Maintenance of DMFs in the OGD’s external website


Letter to DMF-holder when all deficiencies have been addressed


When requested by a DMF holder within 10 days of receiving a first-cycle deficiency letter, the agency will grant a 30


minute teleconference to the DMF holder.


Perform relevant research on BE of locally acting products, effects of excipients on permeability and absorption, post-
marketing surveillance and physicochemical characterization of complex drug substances


Generic drugs play in providing more affordable, therapeutically equivalent medicine, the Generic Drug User Fee
GDUFA FEE:

program is designed to keep individual fee amounts as low as possible to supplement appropriated funding to ensure that
consumers continue to receive the significant benefits offered by generic drugs which provided more than $824 billion dollars
in savings to the nation’s health care system in the last decade alone.
FDA has tentatively finalized the user fee for generics. Under GDUFA the generic player need to pay the fee to the FDA
agency for Type-II DMF and ANDA submission and facilities. The detailed fee applicability and fee structure has represented in
the table-1; Figure-7.


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Figure-7: GDUFA user fee

Figure-8: GDUFA user fee applicability and fee types


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Application Fees:

Backlog fees are in year 1 [(Year 1 Oct 1, 2012 to Sept 30, 2013) for ANDAs pending review at the date of program
Backlog fees:

implementation] and ANDA and Post-Approval Study (PAS) fees, as well as DMF first reference fees in all years.

Both finished dosage form manufacturer and API facilities with a modest fee differential reflecting the added costs of
Facility Fees:

overseas inspection.

Fees will be derived from both applications and facilities in a 30%-70% split. Fees will be split between finished
Source of Fees:

dosage form manufacturers and active pharmaceutical ingredient manufacturers in an 80%-20% split.

As per the GDUFA agreement all API, Finished Dosage Forms (FDF) facilities and applicants of DMF, ANDA are need to
GDUFA Fee agreement:

pay the user fee. Details of GDUFA fee agreement are,
Funding level = inflation adjusted $299M/year
 Fees for Applications and Facilities

Applications in the backlog (year 1 only)  Involved in manufacture of generic drugs,
Applicants Facilities

Drug master file fee whether Active Pharmaceutical Ingredient (API)


ANDA and prior approval supplement (PAS) filing or Finished Dosage Form (FDF), domestic or


fee foreign.


Exemption from fees: Positron Emission Tomography (PET) drugs
Individual fees calculated/published upon implementation and Order of magnitude lower than PDUFA fees



80% from finished dosage form manufacturers, 20% from API manufacturers
 Critical splits:

70% from facility fees, 30% from application fees


In year 1, $50M from backlog fee, so above splits are slightly different



Figure-9: GDUFA user fee partition


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Total revenue for 2013 is as follows,
Table-1: USFDA total revenue for FY 2013

Backlog Fee ------ $ 50
Fee type % as per the GDUFA After partition from $ 299

ANDA/PAS 24% $ 59.8
DMF 6% $ 14.9
API Facility 14% $ 34.9
FDF Facility 56% $ 139.4
100% $ 299
Table-2: User fee details as per the GDUF Act
Total Value

Backlog Fee
Requirement Payment 1st year statutorily directed revenue target Effective date

Pending ANDA applications as on Oct- Once $50 million divided by the total No. of Original Oct-31st 2012
frequency and method of calculating individual fee

1, 2012 without a tentative approval ANDAs pending on Oct-1, 2012

 Any original ANDA that has not been withdrawn, tentatively approved, or approved by September 28, 2012, is
Details:

considered pending and is subject to a backlog fee.
 The backlog fee will be determined based on the number of original ANDAs pending at the start of the business day on
October 1, 2012. In accordance with GDUFA, FDA will divide $50 million by the number of original ANDAs pending to
arrive at the amount of the individual one-time backlog fee, which will be due for each pending original ANDA.
 Absent withdrawals, there could be 3,000 pending original ANDAs on October 1, 2012. A number of these applications
are old and incomplete and may be withdrawn by applicants prior to October 1, 2012 to avoid incurring the backlog
fee.
 The ANDA applicant should notify the Office of Generic Drugs (OGD) in writing with the request to withdraw the
application. To avoid the backlog fee, written notification must be received by September 28, 2012.
 One-time calculation for FY13 and remains in effect for FY14-17.
Fee = $50 Million / number of ANDAs in backlog population
(Example: If backlog population = 2000 ANDAs, then fee is $25,000 for each ANDA).
DMF Fee
Requirement Payment frequency 1st year statutorily directed Effective
revenue target and method date

A type II API-DMF holder whose DMF Once for each API-DMF, no later ~$15 million divided by Oct-31st
of calculating individual fee

is referenced by an initial letter of than when first letter of current estimates of annual No. 2012
authorization in a generic drug authorization is submitted. of DMF application
submission on or after Oct-1st 2012

 Only type-II API DMFs need to pay the GDU fee and effective date is Oct-1st 2012
Details:

 GDUFA does not make a distinction between DMFs submitted before or after October 1, 2012. Holders of DMFs
reviewed prior to GDUFA implementation must pay the one-time DMF fee if their DMF is referenced in a new generic
drug submission on or after October 1, 2012
 A one-time application fee for a Type II Drug Master File (DMF) that is to be referenced on or after October 1, 2012 in a
generic drug submission (new ANDA, supplement or amendment).
 A Type II DMF covers the manufacture of an active pharmaceutical ingredient (API) or drug substance.
 DMF fee can be paid by DMF holder before a letter of authorization requested by the ANDA holder. The advantage for
DMF holders are the Fee paid DMF will undergo an initial completeness assessment by USFDA using the factors
(factors will be published in forthcoming USFDA guidance) and if DMF passes the completeness assessment it will be
placed on a publicly available list of DMF available for reference
 FY13 Fee = 6% of $249 Million / number of estimated Type II DMFs referenced for the first time in FY13. (Example: If
Type II DMFs = 350, then DMF fee is $42,686.)
 DMF fee is incurred when a generic drug submission references the Type II DMF for the first time on or after October
1, 2012.
 The FY13 fee due date is dependent on the later of the following:


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Date of first generic drug submission that references Type II DMF
30 calendar days after fee amount is published in the Federal Register


30 calendar days after enactment of appropriations act


Generic Drug Submission Fees
Requirement Payment 1st year statutorily directed revenue target and Effective

ANDA and PAS Fee: An applicant Once, at time ~$60 million divided by a weighted average of Oct-31st
frequency method of calculating individual fee date

submitting an ANDA or PAS on or of submission current estimates of annual ANDA and PAS 2012
after Oct-1st 2012 of ANDA or applications.
Fee for API not referenced to as (a) PAS (a)(3) (F) ^Fee is expected to generate a small Oct-31st
(3) (F) fee ^ portion of the total above. 2012

 Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application (ANDA) or a prior
Details:

approval supplement (PAS) shall be subject to a fee.
 User fees are required for all PASs (including labeling) that require prior approval under FDA regulations.
 Changes-Being-Effected (CBE-0 and CBE-30) supplements are not required to pay a user fee. FDA reserves the right to
change any CBE to a PAS. If changed, the applicant will be notified to resubmit its application as a PAS and to pay the
PAS user fee.
 For FY13, 24% of $249 million will be collected for ANDA/PAS fees. This amounts to $59.76 million.
 ANDA applications may cost about $56,000 per application. PAS applications will be half that amount at $28,000 per
application.
 The FY13 fee due date is dependent on the later of the following:
 Date of ANDA / PAS submission
 30 calendar days after fee amount is published in the Federal Register
 30 calendar days after enactment of appropriations act
^ The information related (a)(3)(F) fee is as follows,
If a generic (ANDA, amendment to an ANDA or a PAS to an ANDA) drug submission includes API information other
than by reference to a DMF – e.g., the applicant manufactures an API in its own facility or facilities – is the applicant
required to pay an additional fee?
Yes. The applicant is required to pay an API-related fee for each API manufactured in its own facility or facilities for
which it has not previously paid an API-related fee. As with a DMF fee, this fee is paid only once.
The amount of the API-related fee is a function of the number of APIs referenced in the application and the number of
facilities in which those APIs are manufactured. If the ANDA references more than one facility as manufacturing each
API, the applicant must pay the API-related fee for each such facility.
Facility Fee
Requirement Payment frequency 1st year statutorily Effective date
directed revenue
target and method
of calculating

Active The owner of a facility identified or Annually ~$174 million total
individual fee

Pharmaceutical intended to be identified, in at API: ~$35 million divided
Ingredient least on generic drug submission by number of API facilities.
(API) that is pending or approved to FDF: ~$139 million divided by number of
Finished produce one or more generic drug FDF facilities.
Dosage Forms finished dosage form (FDF) and or Facilities located outside of the US and its
(FDF) APIs territories and possessions will pay a higher
fee reflecting the increased costs of
inspection.

 Facilities that manufacture or intend to manufacture generic drugs active pharmaceutical ingredients(API),
Details:

finished dose formulas(FDF), or both
 Sites and organizations that pack human generic drugs
 Sites where bioanalytical studies are conducted
 Sites where clinical research is conducted
 Sites where contract analytical testing is conducted

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Facilities that produce positron emission tomography(PET) drugs or API of such drugs
For FY13, the target revenue will be divided by the number self-identified API and FDF facilities, adjusted for


expectations about how many of each will be located outside the US. The statute calls for a differential to be applied


to foreign facilities, and dictates that the difference be at least $15,000 and not more than $30,000 above the
analogous amount for a US facility.
The FY13 fee due date is dependent on the later of the following:
 45 calendar days after fee amount is published in the Federal Register


 30 calendar days after enactment of appropriations act
The facility will be placed on a publicly-available arrears list if the facility fee is not paid in full within 20 days of the
due date.


No new abbreviated new drug application (ANDA) referencing such facility will be received.
All APIs and FDFs manufactured in such facilities will be deemed misbranded.



FDA has released the user fee process details for generics and it includes the cover sheet and user registration for fee
GDUFA FEE PAYMENT PROCESS:

payment. The high level process for submitting a Generic Drug User Fee Cover Sheet is:
1. Register in the User Fee System by creating a secure user account
2. Submit a Generic Drug User Fee Cover Sheet electronically
3. Submit a payment for the Generic Drug User Fee Cover Sheet
All generic drug organization can initiate the fee payment process from Oct-1 2012 and for user fee payment applicant
need to create the GDUFA cover sheet. This cover sheet will calculate the fee value for all type of user fees. User fee should be
paid after completing the generation of GDUFA cover sheet.

Figure-10: GDUFA user fee payment process steps


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GDFUA fees apply only to generic drug manufactured for human use.
GDUFA cover sheet creation:

Payment submission: Generic applicant can pay the user fee by using Automated Clearing House (ACH) direct deposit
or Credit card payment (Pay.gov) or send payment by check, bank draft, U.S. postal money order, or wire transfer. Payment
must be made in U.S currency drawn on a U.S. bank by electronic payments. Generally, USFDA will not invoice for fee’s and
expects that firms will self-identify and pay. However, in rare and unusual circumstances, USFDA may find it necessary to issue
an invoice. Positron Emission Tomography (PET) drug manufacturers are the only human generic drug manufacturers
excluded from payment of GDUFA fees. They are, however, required to self-identify. PET manufacturers should complete a
generic drug user fee cover sheet for $0.
No reduced fees available for small business or others. As USFDA determines that small generic companies are expected to
benefit significantly from reductions in the review time needed to commercialize their products and from the certainty
associated with performance review metrics and program efficiencies.
Please visit the for GDUFA user fee payment for all type of payments.
https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp
Review of Generic drug submissions post GDUFA
USFDA will expedite review of paragraph IV ANDA application that is submitted on the first day that any valid Paragraph IV
application for the drug in question is submitted. This added to current expedite process like President’s Emergency Plan for
AIDS Relief (PEPFAR), product for which a nationwide shortage has been identified, etc.
GDUFA adds a new requirement to USFDA’s existing refuse to receive policy with respect to payment of fees and the time of
receipt of an ANDA.
Failure to pay an ANDA fee within 20 calendar days of the applicable due date will result in the ANDA not being received.
Failure to pay the fee for a DMF referenced in the ANDA within 20 calendar days of the date that FDA provides


notification of that failure will result in the ANDA not being received.


Failure to pay a facility fee for any facility referenced in the ANDA within 20 calendar days of the date that FDA provides
notification of that failure will result in the ANDA not being received.


If an application is substantially complete except for failure to pay the ANDA fee, or the failure to pay the facility fee
within 20 days of notification, the application will be deemed received as of the date the fee is paid.


FDA will publish further guidance on any other changes to its refuse to receive policy for public comment in advance of their
implementation.
USFDA continue to accept applications in paper format for the time being. Applications received in paper format after October
1, 2012, however, will not be included as part of the new performance metrics established in GDUFA. Additionally, electronic
submissions will be required 24 months after issuance of final electronic submission guidance.

complete response Level: An applicant may request a 30-minute teleconference within ten business days after FDA issues a
Process for requesting a teleconference to clarify deficiencies and answer questions following FDA’s issuance of a

first-cycle review complete response letter to discuss the deficiencies noted in the letter. The request for a teleconference
must be submitted in writing to the ANDA file and appropriately identified on its cover page as a “Post Complete Response
Teleconference Meeting Request.” The request should include a list of specific written questions for discussion. The scope of


128


the questions should be limited to the content of FDA’s complete response letter. Priority for such teleconferences will be
given to expedited and first major amendment applications and other applications

After October 1, 2012, any ANDA/PAS not considered to have been received for scientific reasons is refunded 75% of
GDUFA Limitations:

the application fee. Refunds for overpayment and payments in error must be requested in writing within 180 days of payment.
The Office of Financial Management (OFM) processes the refunds. All inquiries regarding refunds should be addressed by
OFM.
Address for Payment (Note: USFDA will not be able to process the payment correctly without Firms GDUFA cover sheet PIN
(Payment Identification Number)).
Check payment by mail: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000.
Check payment by delivered by a courier service: U.S. Bank, Attn: Government Lockbox 979108, 1005 Covention Plaza, St.
Louis, MO 63101.
Wire Transfer Payment:

New York Federal Reserve Bank, US Department of Treasury,
TREAS NYC, 33 Liberty Street, New York, NY10045
FDA Deposit Account Number: 75060099
US Department of Treasury Routing/Transit number: 021030004
SWIFT Number: FRNYUS33

1350 Piccard Drive, Suite 200A, Rockville, MD20850.
Beneficiary: FDA

If needed for accounting purposes, FDA’s tax identification number is 53-0196965.

Note: a) Wire Transfers to the Department Of The Treasury are distinct from online ACH payments via Pay.gov.

b) If wire transfer done by financial institutions than the fees should include the fees for handling wire transfers.
c) The total fee amount should be paid at least 1 day before the submission arrives at USFDA.

1) The date the submission was received by USFDA (If fees paid earlier to this date).
FDA records as the submission receipt date the later of the following:

2) The date USFDA is notified that payment has been received (If ANDA submitted earlier to this date).

Phone: (301) 796-7200
User Fee Helpdesk:

Email: userfees@fda.gov
Mail: Food and Drug Administration, User Fees Financial Support Team, 1350 Piccard Drive, Suite 200A, Rockville, MD20850.


129


Figure-11: GDUFA user fee Details and Time lines

GUDFA implementation will provide additional funds to USFDA. These additional funds will help the USFDA to
CONCLUSION

increase the facility inspections, speed up the review process and increasing the data base management. In turn to GDUFA
implementation, USFDA like to provide the significant benefit to industries from reductions in the review time needed to
commercialize their products and from the certainty associated with performance review metrics and program efficiencies.
Further, USFDA provided metric goal/measurement for Original ANDA review as
60% of submission within 15 months for FY 2015
 75% of submission within 15 months for FY 2016
 90% of submission within 10 months for FY 2017
 Expedite paragraph IV (Day 1 submissions) submission FY 2013 and FY 2014

For Backlog metrics, the review and act on 90% of backlog applications pending on Oct 1, 2012 by end of FY 2017.

The authors do not claim anything; the purpose of this review is solely educational. This article is built on the
DISCLAIMER

information provided by the public USFDA CDER domain website

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1. CDER’s MAPP 6050.1, Refusal to Accept Application for Filing From Applicants in Arrears.
REFERENCES

2. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm.
3. Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act, and its addendum at the guidance Web page.
4. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
5. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm.
6.
7. http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf
FDA guidelines: Self-Identification of Generic Drug Facilities, Sites, and Organizations.

9. http://www.drugstorenews.com/article/generic-drug-user-fee-act-passes-senate
10. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm316790.htm
11. http://www.gpo.gov/fdsys/pkg/FR-2012-07-26/html/2012-18232.htm
12. http://pharma.about.com/od/FDA/a/2012-Renewal-Of-The-Prescription-Drug-User-Fee-Act-Pdufa.htm
13. http://www.rediff.com/money/report/us-to-charge-fee-on-generic-drug-sale-application/20120621.htm
14. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm316790.htm
15. https://userfees.fda.gov/OA_HTML/gdufaFAQ.html
17. http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061432.html
18. https://smallbusiness.dnb.com/establish-your-business/12334338-1.html
19. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm0731
64.htm
20. http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061432.htm
21. https://smallbusiness.dnb.com/establish-your-business/12334338-1.html
22. http://www.fda.gov/edrls

24. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM322676.pdf
23. http://www.fda.gov/RegulatoryInformation/FOI/PrivacyAct/


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Usfda generic drug user fee act a complete review

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Usfda generic drug user fee act a complete review