Regulatory Buddy’s Post

Happy New Year 2024

Type C meeting under PDUFA Act: These meetings are conducted to discuss development and review of the drug under investigation. You may want to request for Type C meeting when neither of Type A, B, D or INTERACT meeting satisfy your criteria for meeting the Agency. Type C meeting among other things is used to discuss the possibility of using a new Biomarker for a surrogate endpoint that was never used as a primary basis of product approval for a given indication. #FDA #FDAMeetings #drugdevelopment #regulatoryaffairs

Type B meetings under PDUFA Act (2 of 2) The second kind of Type B meetings are End of Phase (EOP) meetings. Typically these are conducted at the end of Phase 1 (EOP 1) or at the end of Phase 2 (EOP 2) to discuss the results of clinical trails from the concluded clinical trials. These meetings also give an opportunity to discuss CMC and Non-clinical development as well. #FDA #regulatoryaffairs #fdameetings #drugdevelopment

Type B meetings under PDUFA Act (1 of 2) There are two types of Type B meetings under PDUFA Act. 1. Meetings before an Initial IND to conduct clinical trials is submitted (Pre-IND meeting). 2. Meetings before submission of Emergency-Use Authorization IND applications (Pre-emergency use authorization meeting). 3. Meetings before a marketing application is submitted (Pre-NDA or Pre-BLA meeting). 4. Meeting to discuss REMS or post marketing requirements (that fall outside of marketing application review). 5. Meetings to discuss development program of investigational drugs that are granted Breakthrough Therapy or Regenerative Medicine Advanced Therapy (RMAT) designation. #FDA #regulatoryaffairs #fdameetings #drugdevelopment

Type A meetings under PDUFA Act discuss one of the following: 1. Dispute resolution meetings for sponsor appeals above the decision level. 2. Clinical hold meetings to discuss resolutions to remove clinical hold. 3. To discuss FDA non-agreement of Special Protocol Assessment. 4. Post-action meeting to discuss FDA's regulatory action (rejection or CRL). FDA approval do not call for this meeting. In this case, meeting should be requested within 3 months of FDA decision. 5. To discuss Refusal to File (RTF) action from FDA. In this case, meeting should be requested within 30 days of RTF decision. #FDA #drugdevelopment #regulatoryaffairs

Another way to know that FDA wants to help your company with your drug development. There are 5 different types of meetings allowed under PDUFA Act. 1. Type A meetings 2a. Type B meetings 2b. Type B (End of the Phase) meetings 3. Type C meetings 4. Type D meetings 5. Interact meetings All these meetings are held at different stages of drug development. All these meetings do not cost anything to the sponsor. #FDA, #drugdevelopment, #regulatoryaffairs

Under PDUFA (Prescription Drug User Fee Act), Sponsors can meet with FDA to discuss their drug development. FDA also allows generic drug developers and Biosimilar drug developers with different kinds of meetings as defined in GDUFA and BSUFA. #drugdevelopment #regulatoryaffairs

No more than 10 questions. That is what FDA suggested in its September 2023 Guidance "Formal Meetings Between FDA and Sponsors or Applicants of PDUFA Products". FDA recommended not asking too many questions or subpart questions to have an effective discussion on a topic. This will be applicable to all types of meetings except Type D meeting where you could discuss 3-5 questions.

Two new meeting types were introduced in a latest guidance document from FDA: "Formal Meetings Between FDA and Sponsors of Applicants of PDUFA Products". 1. Type D Meeting: This meeting will focus on narrow set of issues such as: a. A follow up question that that you may have after a formal meeting b. A specific issue with 3-5 associated questions c. Questions around an innovative approach that do not need an extensive discussion. 2. INTERACT Meeting: This meeting is to discuss early development of some Innovative development programs (eg: Cell and Gene Therapy or 3D Printing Technology). This meeting is the earliest you can meeting with FDA (even before Pre-IND meeting). FDA expects to submit Meeting Package at the time of Meeting Request submission for both the above meeting. Actual meeting or written responses are scheduled 50 and 75 days after submission of Meeting Request respectively for Type D and INTERACT meetings.

For those who don't already know: FDA updated its guidance document "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" in September 2023. Previous edition of the same guidance was published in December 2017. https://lnkd.in/gFunyDqZ