FDA Releases Draft Guidance for Industry On Formal Meetings With Drug Sponsors

The Food and Drug Administration March 10 released a draft guidance for industry on formal meetings between the agency and sponsors relating to the development and review of drug or biological products.

A notice announcing the draft guidance was published in the March 11 Federal Register (80 Fed. Reg. 12,822).

For the purposes of the draft guidance, a formal meeting includes any meeting that is requested by a sponsor or applicant following the request procedures provided in the guidance and includes meetings conducted in any format (i.e., in person, by teleconference, video conference or written response), the ...