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Useni Reddy Mallu et al.

, IJSID, 2012, 2 (5), 117-131

ISSN:2249-5347

IJSID

International Journal of Science Innovations and Discoveries


Research Article

An International peer Review Journal for Science

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 Accepted: 18-10-2012


*Corresponding Author

ABSTRACT medicines, bio-Similar, colors, exports, tobacco and medical devices. After several 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. applications including the prioritization of the paragraph-IV. File (DMF), ANDA, and GDUFA cover sheet. INTRODUCTION USFDA team, speed up the facility inspections and approval process of all types of USFDA has implemented several types user fee acts for human and animal

discussion and negotiations with Generic Pharmaceutical Association (GPhA), USFDA has The main intention to implement the user fee is to increase the number of reviewers in

Address: Name: Dr. Useni Reddy Mallu Place: Sri Krishnadevaraya University Anantapur, AP, India. E-mail: drusenireddymallu@gmail.com

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

INTRODUCTION

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

Background:

the industry. The collected fees are used to provide the safety and effective medicines to the patients. FDA has user fees for has collecting the user fee from manufacturer.

human and animal drugs, medical and mammography devices, color additives, exports and tobacco products. The Division of humans and animals. The lists of user fee acts are represented below.

User Fees (DUF) is responsible for the overall management of the program, Office of Financial Management (OFM). The OFM USFDA has implemented about thirteen user fee acts for protecting health and providing safety, efficacy medicines for

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

1. Animal Drug User Fee Act (ADUFA) 3. Bio similar User Fee Act (BsUFA) 4. Color Certification (CERTS) 5. Exports Certificate (Exports)

2. Animal Generic Drug User Fee Act (AGDUFA)

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) 13. Tobacco Product Fees 10. Mammography Quality Standards Act (MQSA) 12. Prescription Drug User Fee Act (PDUFA)

11. Medical Device User Fee and Modernization Act (MDUFMA)


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 backlog details and inspections in the last 10 years (The below figures are copied from the public FDA websites).

through GDUFA amendments 2012. Figure-1 to 5 represents increasing the Type-II DMFs and ANDAs application submissions,

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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.

Origin of GDUFA:

2010: Initiation of USFDA discussions.

2011: FDA has conducted the meetings with GPhA for negotiations and Implementing, drafting the GDUFA.

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

2012: On July 9, 2012, GDUFA was signed into law by the President. GDUFA draft Guidelines released on Sep-2012. International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012

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Why GDUFA is required?

appropriated by Congress. User fee for generic drugs provides the funding to achieve the same surveillance inspection are held to consistent good manufacturing practice (GMP) standards. The three strong scopes of GDUFA are:

frequency for both domestic and foreign manufacturers to insure that all industry participants in the U.S. generic drug system

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

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

to consistent high quality standards and are inspected biennially, using a risk-based approach, with foreign and domestic parity. times for ANDAs, amendments and supplements. Access: Expedite the availability of low cost, high quality generic drugs by bringing greater predictability to the review International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012

Safety: Ensure that industry participants, foreign or domestic, who participate in the U.S. generic drug system are held

Figure-6: GDUFA Key Goals

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identification of facilities involved in the manufacture of generic drugs, active pharmaceutical ingredients, and improving FDAs communications and feedback with industry in order to expedite product access. GDUFA Goals: GDUFA are,

Transparency: Enhance FDAs ability to protect Americans in the complex global supply environment by requiring the USFDA have a proposal for increasing the facility inspections, speed up the review process, increasing the data base

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management, immediate response letters to the applicant and special focus on paragraph-IV submissions. The main goals of Backlog API DMF and ANDAs review Increase the Regulatory Research Speed up the review process for all submissions Prioritization of Paragraph-IV submission minute teleconference to the DMF holder. Increase the facility inspections (Domestic and Foreign) Maintenance of DMFs in the OGDs 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 marketing surveillance and physicochemical characterization of complex drug substances

Perform relevant research on BE of locally acting products, effects of excipients on permeability and absorption, postGeneric 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 in savings to the nations health care system in the last decade alone. the table-1; Figure-7.

consumers continue to receive the significant benefits offered by generic drugs which provided more than $824 billion dollars

agency for Type-II DMF and ANDA submission and facilities. The detailed fee applicability and fee structure has represented in

FDA has tentatively finalized the user fee for generics. Under GDUFA the generic player need to pay the fee to the FDA

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Figure-7: GDUFA user fee

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Figure-8: GDUFA user fee applicability and fee types

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Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131 Application Fees: Backlog fees: implementation] and ANDA and Post-Approval Study (PAS) fees, as well as DMF first reference fees in all years. Facility Fees: overseas inspection. Source of 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 Both finished dosage form manufacturer and API facilities with a modest fee differential reflecting the added costs of

dosage form manufacturers and active pharmaceutical ingredient manufacturers in an 80%-20% split. GDUFA Fee agreement: pay the user fee. Details of GDUFA fee agreement are, Fees for Applications and Facilities Applicants Funding level = inflation adjusted $299M/year

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

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

Applications in the backlog (year 1 only) Involved in manufacture of generic drugs, 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 Facilities Individual fees calculated/published upon implementation and Order of magnitude lower than PDUFA fees Critical splits: 80% from finished dosage form manufacturers, 20% from API manufacturers 70% from facility fees, 30% from application fees In year 1, $50M from backlog fee, so above splits are slightly different

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Figure-9: GDUFA user fee partition

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Total revenue for 2013 is as follows, Fee type Backlog Fee ANDA/PAS DMF API Facility FDF Facility Total Value

Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131 Table-1: USFDA total revenue for FY 2013

Pending ANDA applications as on OctOct-31st 2012 1, 2012 without a tentative approval Details: Any original ANDA that has not been withdrawn, tentatively approved, or approved by September 28, 2012, is 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 of calculating individual fee A type II API-DMF holder whose DMF Once for each API-DMF, no later ~$15 million divided by Oct-31st 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 Details: Only type-II API DMFs need to pay the GDU fee and effective date is Oct-1st 2012 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: International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012

Requirement

% as per the GDUFA After partition from $ 299 -----$ 50 24% $ 59.8 6% $ 14.9 14% $ 34.9 56% $ 139.4 100% $ 299 Table-2: User fee details as per the GDUF Act Payment frequency Once Backlog Fee 1st year statutorily directed revenue target and method of calculating individual fee $50 million divided by the total No. of Original ANDAs pending on Oct-1, 2012

Effective date

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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 frequency method of calculating individual fee date ANDA and PAS Fee: An applicant Once, at time ~$60 million divided by a weighted average of Oct-31st 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. PAS Fee for API not referenced to as (a) (a)(3) (F) ^Fee is expected to generate a small Oct-31st (3) (F) fee ^ portion of the total above. 2012 Details: Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application (ANDA) or a prior 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 individual fee Active The owner of a facility identified or Annually ~$174 million total 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 produce one or more generic drug FDF facilities. Finished finished dosage form (FDF) and or Facilities located outside of the US and its Dosage Forms APIs territories and possessions will pay a higher (FDF) fee reflecting the increased costs of inspection. Details: Facilities that manufacture or intend to manufacture generic drugs active pharmaceutical ingredients(API), 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 International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012

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payment. The high level process for submitting a Generic Drug User Fee Cover Sheet is: 1. 2. 3. Register in the User Fee System by creating a secure user account Submit a Generic Drug User Fee Cover Sheet electronically Submit a payment for the Generic Drug User Fee Cover Sheet

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:

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.

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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.

All generic drug organization can initiate the fee payment process from Oct-1 2012 and for user fee payment applicant

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Figure-10: GDUFA user fee payment process steps

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Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131 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 fees and generic drug user fee cover sheet for $0. an invoice. Positron Emission Tomography (PET) drug manufacturers are the only human generic drug manufacturers No reduced fees available for small business or others. As USFDA determines that small generic companies are expected to associated with performance review metrics and program efficiencies. Review of Generic drug submissions post GDUFA Please visit the for GDUFA user fee payment for all type of payments. https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp excluded from payment of GDUFA fees. They are, however, required to self-identify. PET manufacturers should complete a

expects that firms will self-identify and pay. However, in rare and unusual circumstances, USFDA may find it necessary to issue

benefit significantly from reductions in the review time needed to commercialize their products and from the certainty

USFDA will expedite review of paragraph IV ANDA application that is submitted on the first day that any valid Paragraph IV AIDS Relief (PEPFAR), product for which a nationwide shortage has been identified, etc. receipt of an ANDA.

application for the drug in question is submitted. This added to current expedite process like Presidents Emergency Plan for 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. 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 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.

GDUFA adds a new requirement to USFDAs existing refuse to receive policy with respect to payment of fees and the time of

FDA will publish further guidance on any other changes to its refuse to receive policy for public comment in advance of their implementation. submissions will be required 24 months after issuance of final electronic submission guidance.

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 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 FDAs issuance of a must be submitted in writing to the ANDA file and appropriately identified on its cover page as a Post Complete Response International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012 first-cycle review complete response letter to discuss the deficiencies noted in the letter. The request for a teleconference

Teleconference Meeting Request. The request should include a list of specific written questions for discussion. The scope of

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the questions should be limited to the content of FDAs complete response letter. Priority for such teleconferences will be given to expedited and first major amendment applications and other applications 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. (Payment Identification Number)). Louis, MO 63101. Check payment by mail: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. 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. If needed for accounting purposes, FDAs tax identification number is 53-0196965. Beneficiary: FDA Address for Payment (Note: USFDA will not be able to process the payment correctly without Firms GDUFA cover sheet PIN Check payment by delivered by a courier service: U.S. Bank, Attn: Government Lockbox 979108, 1005 Covention Plaza, St. After October 1, 2012, any ANDA/PAS not considered to have been received for scientific reasons is refunded 75% of

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Note: a) Wire Transfers to the Department Of The Treasury are distinct from online ACH payments via Pay.gov. FDA records as the submission receipt date the later of the following: 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).

b) If wire transfer done by financial institutions than the fees should include the fees for handling wire transfers. 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.

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increase the facility inspections, speed up the review process and increasing the data base management. In turn to GDUFA 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 DISCLAIMER

implementation, USFDA like to provide the significant benefit to industries from reductions in the review time needed to

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

Figure-11: GDUFA user fee Details and Time lines

information provided by the public USFDA CDER domain website International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012

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

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Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131 1. 2. 3. 4. 5. 6. 7. 8. 9. CDERs MAPP 6050.1, Refusal to Accept Application for Filing From Applicants in Arrears. REFERENCES http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm. FDA guidelines: Self-Identification of Generic Drug Facilities, Sites, and Organizations. http://www.drugstorenews.com/article/generic-drug-user-fee-act-passes-senate http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm.

Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act, and its addendum at the guidance Web page. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM296451.pdf

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 15. https://userfees.fda.gov/OA_HTML/gdufaFAQ.html 14. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm316790.htm 16. http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf 17. http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061432.html 18. https://smallbusiness.dnb.com/establish-your-business/12334338-1.html

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

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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