FDA Publishes Best Practices for Communication Between IND Sponsors and FDA During Drug Development - Big Molecule Watch

Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”  The guidance is intended to “describe best practices and procedures for timely, transparent, and effective communications between [IND] sponsors and FDA at critical junctures in drug development.”  This guidance applies, in particular, to the IND phase of drug development, including for biosimilars.

The guidance describes: FDA’s philosophy regarding timely communications with IND sponsors; the scope of appropriate interactions between review teams and IND sponsors; what types of advice are appropriate for IND sponsors to seek from FDA; expectations for the timing of FDA responses to IND sponsor inquiries; best practices and communication methods to facilitate interactions with FDA; and expectations for appropriate methods and frequency of communication with FDA.

Specific to biosimilars, the guidance describes meetings under the Biosimilar User Fee Act (BsUFA), referred to as Biosimilar Initial Advisory (BIA) and biological product development (BPD) Type 1 through Type 4 meetings.  These meetings are “based on the stage of development of the biosimilar product and on the amount and type of data and information provided to support the meeting.”

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