FDA Meetings, Review Issues & Dispute Strategy

Well-planned and successful FDA engagement can mean the difference between an efficient path to approval and a stalled development program. Despite the mantra "early and often," FDA review divisions contend with meaningful resource limitations. The timing and substance of FDA meetings and engagement are therefore critical. Asking the right questions, presenting well-supported proposals, reducing to writing shared views or agreements, and seeking agency buy-in are all key to effective engagement. We help clients foster positive review team engagement and buy-in, anticipate and address challenges, and push back on FDA when necessary through informal and formal means.

We advise on:

• FDA meeting strategy, briefing books, and preparation
• Review-cycle communications and information requests
• Advisory committee preparation
• Clinical holds
• Refusal-to-file letters and pre-filing disputes
• Complete response letters
• Formal dispute resolution requests (FDRRs)
• Labeling, REMS, and post-approval negotiations

Selected Experience

• Helped sponsor prepare for successful advisory committee, including preparation of messaging, slides, and Q&A.
• Planned, prepared, and attended a Type C meeting with the FDA review division on a stalled development program, identifying a path forward ultimately leading to approval.
• Faced with a "General Advice" letter from the review division, addressed concerns prior to PDUFA date while preparing arguments for an expected CRL, and ultimately overcame the CRL through Type A EOR meeting and FDRR work without additional studies.
• Assisted on a successful FDRR addressing the need for an additional adequate, well-controlled clinical trial, allowing for sponsor resubmission and approval without an additional clinical trial.
• Led successful NDA resubmission, addressing issues related to strength of clinical evidence, quality, and regulatory flexibility.
• Overcame multiple CRLs on drug-device issues for a 505(b)(2) combination drug-device approval, working closely with patent counsel.