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Draft Guidance on Formal Meetings Between Applicants and FDA

Friday, March 20, 2015   (0 Comments)
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The FDA announced the availability of a draft guidance for industry entitled, “Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products." This draft guidance document is intended to provide recommendations on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products, and revises the guidance for industry published in 2009. 

Significant changes from the 2009 version include: 

  • Addition of the written response meeting format for pre-investigational new drug application (pre-IND) and Type C meetings
  • Designation of a post-action meeting requested within 3 months after an FDA regulatory action other than approval as a Type A meeting
  • Designation of a post-action meeting requested 3 or more months after an FDA regulatory action other than approval as a Type B meeting 
  • Designation of a meeting regarding risk evaluation and mitigation strategies (REMS) or post-marketing requirements that occur outside the context of the review of a marketing application as a Type B meeting 
  • Inclusion of a meeting package in Type A meeting requests
  • Designation of meetings to discuss the overall development program for products granted 59 breakthrough therapy designation status as a Type B meeting

Comments and suggestions regarding this draft document should be submitted by June 9, 2015. Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with Docket No. FDA-1999-D-1315 (formerly 1999-D-0296).


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