FDA Meetings Consulting

Optimize Every ODD FDA Meeting with Expert Preparation

Trusted Authority in FDA & EMA Orphan Drug Designation

95% First-Attempt FDA Application Success Rate

Expert Guidance from the Former FDA Director of Orphan Products

Comprehensive FDA Meeting Preparation & Support

Only Orphans Cote helps biotechs secure critical designations like Fast Track and Breakthrough Therapy, both designed to speed development and review of promising drugs. We guide sponsors from eligibility assessment through submission and FDA interactions, ensuring your program is positioned for success.

Meetings with the FDA are critical checkpoints in orphan drug designation, from early-stage advice to resolving urgent regulatory challenges. Only Orphans Cote helps biotech teams prepare, present, and follow through so each interaction with the Agency moves your program forward.


With experience across all meeting types — INTERACT, Pre-IND, Type A, B, C, and D — our team ensures you maximize FDA resources, anticipate questions, and avoid costly delays.

Our FDA Meeting Support Includes:

  • Drafting and refining FDA meeting requests and briefing packets
  • Ensuring all materials comply with FDA guidance and expectations
  • Coordinating subject matter experts for technical accuracy
  • Moderating FDA meetings, virtually or on-site in Maryland, USA
Only Orphans Cote - Trusted by 180+ Biotech & Pharmaceutical Companies Worldwide

Orphan Drug FDA Meeting Types


FDA INTERACT Meeting

Initial Targeted Engagement for Regulatory Advice on CDER and CBER Products

An INTERACT meeting provides early FDA feedback for novel or complex products before IND filing or a pre-IND meeting. This “blue sky” meeting clarifies requirements and helps sponsors avoid delays when planning first-in-human studies.


FDA Pre-IND Meeting

A Pre-IND meeting (Type B) is held before submitting an Investigational New Drug application. Sponsors use it to discuss:

  • Clinical development strategy
  • Toxicology and CMC requirements
  • First-in-human study design

The outcome is an IND package that aligns with FDA expectations and minimizes the risk of clinical hold.


FDA Type B Meeting

Routine milestone meetings, including Pre-IND, End-of-Phase, Pre-BLA/NDA, or discussions for breakthrough/RMAT products.


FDA Type C Meeting

Any other product development meeting outside A, B, D, or INTERACT, including discussions of complex scientific questions or innovative endpoints.


FDA Type D Meeting

Narrowly focused meetings on one or two issues or follow-up questions requiring timely FDA feedback without the scope of a full Type C.


FDA Type A Meeting

Type A meetings are typically less common. They are reserved for urgent or stalled development programs and address:

  • Clinical holds
  • Disputes or regulatory roadblocks
  • Refuse-to-file or complete response letters


Why Partner with Only Orphans Cote for FDA Meetings?

Every FDA meeting shapes your path forward. With Only Orphans Cote, you gain the immediate advantage of our:


Proven Expertise -  Decades of experience across rare disease and novel therapy programs.


Efficient Strategy -  Anticipate FDA concerns and align your meeting plan to minimize delays.



Hands-On Support -  From briefing booklets to live FDA meeting moderation, we guide every step.


Get Help with ODD FDA Meetings Today

Preparing for an FDA meeting? Our team will review your program and outline a strategy to get the most from your Agency interaction. From briefing packets to live moderation, we’ll help you enter every FDA meeting ready to succeed.