OTP INTERACT Meetings | FDA - U.S. Food and Drug Administration
2024年8月22日 · SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products states that INTERACT Meetings will be held within 75 calendar days of receipt of the meeting...
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FDA In Brief: FDA announces program to enhance early …
INTERACT meetings will enable sponsors to engage with the FDA early in the development process and obtain advice on a wide range of development-related topics.
Interactions with Office of Therapeutic Products | FDA
2024年8月22日 · Before requesting an INTERACT meeting, a sponsor should have identified the investigational product to be evaluated in a clinical study and conducted some preliminary preclinical proof-of-concept ...
The INTERACT meeting allows sponsors to obtain preliminary informal feedback on CMC, Non-clinical, and Clinical issues for innovative investigational products earlier in development than the pre-IND stage.
Through an INTERACT meeting, sponsors can obtain initial, non-binding advice from FDA regarding chemistry, manufacturing and controls, pharmacology/toxicology, and/or clinical aspects of the development program.
FDA Meeting Series: How, When and What – INTERACT Meetings
2023年9月28日 · INTERACT meetings are intended to facilitate IND-enabling efforts when the sponsor is facing a novel, challenging issue that might otherwise delay progress of the product toward entry into the clinic in the absence of this early FDA input.
FDA Brings its Formal Meetings Guidance Up to Date: What You …
2023年9月28日 · For INTERACT meetings, FDA intends to respond to a meeting request within 14 days of receipt and to schedule a meeting or issue written responses within 75 days from receipt of the meeting request. FDA intends to provide preliminary responses to INTERACT meeting packages no later than 5 calendar days before the meeting date.
FDA INTERACT meetings - Cardinal Health
Cell and gene therapy development programs are highly complex — and managing them effectively requires well-planned interactions with the FDA through all stages of development – starting with the INTERACT meeting. FDA reviewers are committed to helping you and your product move forward.
Type A Meeting - A meeting which is necessary for an otherwise stalled drug development program to proceed (a “critical path” meeting) or to address an important safety issue.