List of Terms & Provisions related to GDUFA in framework for Generic Drugs:--

Yes, there are several other terms and provisions related to GDUFA:

1. *ANDA*: Abbreviated New Drug Application, required for generic drug approval.

2. *DMF*: Drug Master File, a document containing confidential information about a drug's manufacturing process.

3. *PAS*: Prior Approval Supplement, required for changes to an approved generic drug.

4. *GDUFA I*, *GDUFA II*, and *GDUFA III*: Successive reauthorizations of the GDUFA program.

5. *BSUFA*: Biosimilar User Fee Act, a similar program for biosimilar products.

6. *PDUFA*: Prescription Drug User Fee Act, a program for innovator drugs.

7. *MFUA*: Medical Device User Fee Act, a program for medical devices.

8. *AGDUFA*: Animal Generic Drug User Fee Act, a program for animal generic drugs.

9. *FY*: Fiscal Year, the annual period for GDUFA fee collection and performance goals.

10. *Performance Goals*: Metrics for FDA review performance, such as review times and approval rates.

11. *User Fees*: Fees paid by industry to support the review process.

12. *Waivers*: Exemptions from user fees for small businesses or certain products.

13. *Self-Identification*: Manufacturers' voluntary reporting of their generic drug products.

These terms and provisions are part of the regulatory framework for generic drugs in the US, aiming to ensure timely access to affordable medicines while maintaining quality and safety standards.