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Best practices for IND submissions, amendments and responding to clinical holds
Summary
OTP advised sponsors to request pre‑IND meetings with focused IND‑enabling questions, submit complete INDs early in the week, include multiple authorized regulatory contacts, and—if placed on clinical hold—wait for the official hold letter and respond with a labeled clinical hold complete response.
Mara Miller emphasized practical steps sponsors can take to keep reviews efficient: request a pre-IND meeting, propose thoughtful IND-enabling questions, and submit complete files. "When we receive INDs on Fridays or Saturdays, we lose valuable review time," she said, recommending submissions early in the week and providing more than one authorized regulatory contact so review teams can reach the sponsor quickly.
On clinical holds, Jessica Behmer told sponsors to wait for the official hold letter listing deficiencies (issued within 30 days), and then address each deficiency in a clearly labeled submission. "When you do respond to the hold, identify your response as a clinical hold complete response in all capital and bold letters in the cover letter," she said, adding that sponsors can request an informal teleconference with the assigned regulatory project manager for clarification.
