Topic outline

• FDA Regulatory Milestones

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    Forum

    Announcements Forum

• Regulatory Submissions and Applications
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• FDA Expedited Programs
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• FDA Meeting Types
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• Formal FDA Meetings

  Formal FDA meetings are statutory FDA meetings in the process of drug development. These include Pre-IND Meeting, End of Phase II Meeting and Pre-NDA Meeting.

  
  

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• FDA Communication Types

  FDA formal meetings generally take one of three formats:​ Face to Face​, Teleconference or Videoconference​ & Written Responses Only (WRO)​. These depend on the the FDA, Sponsor and type of meeting.
  

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• Useful Regulatory Terminologies in Drug Development

  Regulatory terminologies range from 'Fast Track' to 'Off Label Use' and many more. This video explains these useful terms in short descriptions.
  

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• Glossary