Seventh Reauthorization of PDUFA

The legislative authority for Prescription drug use fee program (PDUFA)-VI expires in September 2022. New legislation, the seventh reauthorization of PDUFA (PDUFA-VII) will go into effect from October 2022 (fiscal year 2023) through 2027. As per the commitment letter, we will be seeing two additions in the types of meetings with the FDA; Type D meeting type and INTERECT meeting for CDER regulated products.

1.??????Type D: Focused on a narrow set of issues (e.g., often one, but typically not more than two issues and associated questions). Requests could include:

·??????A follow-up question that raises a new issue after a formal meeting (i.e., more than just a clarifying question about an FDA response from a prior meeting);

·??????A narrow issue on which the sponsor is seeking Agency input with only a few associated questions; or

·??????A general question about an innovative development approach that does not require extensive, detailed advice

2.??????INTERACT INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs : Meetings intended for novel questions and unique challenges in early development (i.e., prior to filing of an IND).

The issues typically relate to IND requirements for example: questions regarding design of IND-enabling toxicity studies (e.g., species, endpoints), complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of cutting-edge testing methodologies.