Tag Archives: FDA

FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants

The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this … Continue reading

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Why Did the Chicken Cross the Road? To Get New Genes!

Jay Cormier has a new post on the FDA Law Blog called “Tastes Like Chicken: Second ‘BioPharm’ Animal Approved to Produce Biological to Treat Orphan Disease Includes 6th Rare Pediatric Disease Priority Review Voucher.” He writes: On December 8, 2015, … Continue reading

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FDA Finalizes Biosimilar Guidance

The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.”  The article includes links to the final guidance documents. You can find the article here.

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Patents4Life is Six Years Old this Month. Happy Birthday to Us!

Six years ago, In re Kubin caused a flurry of concern among biotech practitioners, and a short article on this decision was the first post on Patents4Life. That was a pretty big “story” at the time but we all had … Continue reading

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