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Message: Re: Thoughts....
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May 23, 2019 07:20AM
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May 24, 2019 08:25AM

Quite a list:

"Examples of type B meetings include:

  • Pre-investigational new drug application (pre-IND) meetings
  • Certain end-of-phase 1 meetings for Subpart E or Subpart H or similar products
  • End-of-phase 2 and pre-phase 3 meetings
  • Pre-new drug application (pre-NDA) pre-biologics license application (pre-BLA) meetings
  • Meetings regarding risk evaluation and mitigation strategies (REMS) or post-marketing requirements that occur outside the context of the review of a marketing application
  • Post-action meetings requested by the sponsor 3 months or more after an FDA regulatory action other than an approval
  • Meetings held to discuss the overall development program for products granted Breakthrough Therapy designation status."

 

Koo

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