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ARTICLE · 17 JANUARY 2019

Five Most Popular IP FDA Blog Posts From 2018

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
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Finnegan, Henderson, Farabow, Garrett & Dunner LLP

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Happy New Year! In case you missed them, here are our five most popular posts from 2018. This has been an exciting year for the Finnegan IP FDA Blog ...

United StatesIntellectual Property
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
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Happy New Year! In case you missed them, here are our five most popular posts from 2018. This has been an exciting year for the Finnegan IP FDA Blog, and we look forward to sharing IP FDA news with you in 2019.

  1. FDA Final Guidance on E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) - This was the most popular post in 2018, covering FDA's March 2018 updates to the original ICH E6(R1) Good Clinical Practice guidance. The final guidance primarily focuses on quality management and monitoring of clinical trials, updating the original guidance based on advances in the use of electronic data recording and reporting.
  2. FDA Final Guidance on Bioanalytical Method Validation - This post was second most popular, covering FDA's final guidance in May 2018 about elements of bioanalytical method development and validation that are needed to ensure the quality of an assay and the reliability of the data it generates. Similar to the most popular post, this guidance

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