Description
This guidance provides answers to anticipated user-fee questions from generic drug industry participants regarding the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA.2 The questions and answers (Q&A) format is intended to promote transparency and facilitate compliance. The first version of this document was issued pursuant to 21 CFR 10.115 and was made available on FDA’s website on August 22, 2012. In response to comments received in the docket and to address additional questions that have arisen since the beginning of GDUFA, FDA issued Revision 1 of the draft guidance on September 10, 2013.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
6Subject of GDUFA and related meeting processes.
Category of drugs excluded from GDUFA fees but requiring self-identification
Submissions that may qualify for a waiver from eCTD requirements
Generic drug product category
Finished Dosage Form manufacturer facility
Positron emission tomography drugs
Stakeholders
10Entity responsible for submitting NDINs
Entity responsible for the manufacturing facility
new facilities added by the DMF holder
Person listed on Form FDA 356h to receive correspondence
Trading partner defined in section 581(16) of the FD&C Act
Entity that packages drug products into container/closure systems
entities meeting user-fee requirements
Entity that controls or is controlled by the applicant; Business entities related to the applicant
entity submitting marketing applications
responsible for assigning new NDC or lot numbers to repackaged products
Regulatory Context
Regulatory Activities
4Abbreviated New Drug Application
New Drug Application
Prior Approval Supplement required for high-risk changes.; Prior Approval Supplement reporting category for manufacturing process changes
Type II API DMFs intended for reference in a generic drug submission that are subject to the DMF fee under GDUFA I
Document Types
5A submission to FDA that may be used to provide confidential information about facilities or processes.; cross-referencing a DMF in a BLA
Drug Master File for active pharmaceutical ingredients
Drug Master File referenced in generic drug submissions
Permits FDA to reference an existing IND
Drug master files; Drug Master File updated with vendor lists
Attributes
4One-time fee for ANDAs pending on October 1, 2012
Required documentation for new FDA submissions
Criteria for determining if separate facility fees are due
New Chemical Entity exclusivity affecting submission timing
Technical Details
Substances
3examples of such components include but are not limited to the active moiety (API)
Substance produced in facilities subject to fees
Active Pharmaceutical Ingredient
Testing Methods
1In vitro bioequivalence testing sites
Processes
1Process of placing drug into a container/closure system
Related CFR Sections (4)
- 21CFR314.103§ 314.103 Dispute resolution.
(a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated applications as quickly and amicably as possible through the cooperative exchange of information and views.Read full regulation →
- 21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
See Also (8)
- Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products (Status: Draft)
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (Status: Final)
- Special Protocol Assessment Guidance for Industry (Status: Final)
- Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff (Status: Final)
- ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry (Status: Final)
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (Status: Draft)
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)