Case Study

Case Study

Case Study

Jan 01, 2022

Has FDA issued a complete response after advisory committee meeting?

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Blog Image
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Challenge
  1. Search for all complete response actions after original or subsequent submissions.

  2. Narrow the search results to those which had advisory committee meetings.

  3. Identify whether having advisory committee meeting followed by CR letter.

  4. Manual search would require going through the reviews of each product - impossible.


Outcomes
  1. RIA helped regulatory experts to quickly identify all products for which there was an advisory committee meeting and received a complete response letter.

  2. RIA further helped interrogate the results by time period, product, formulation or sponsor.

Why Vivpro?

RIA saves time and delivers intelligence at high quality EQUALS TO more time for strategy.

Vivpro RIA

Competition

Manual

Time Efficient: Result in 15 mins

Less Time Efficient: Result in 1 day

Time Inefficient: Result in 3 days

Top Quality Result: Human & Machine Assisted

Normal Quality: ResultMachine Assisted

Ok Quality Result: Human Assisted