Best Practices for Communication Between IND Sponsors and USFDA During Drug Development

Guidance for Industry and Review Staff

The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public. This guidance applies to communications between IND sponsors and FDA during the IND phase of drug development, including biosimilar biological product development (BPD). This guidance describes:

  • FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity
  • The scope of appropriate interactions between review teams and IND sponsors
  • The types of advice appropriate for IND sponsors to seek from FDA in pursuing their drug development programs
  • General expectations for the timing of FDA response to IND sponsor inquiries
  • Best practices and communication methods to facilitate interactions between review teams and IND sponsors during drug development
  • Expectations for appropriate methods, including the frequency, of such communications
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