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India’s Stem Cell Guidelines Mandate Additional Checks

 
• By Anju Ghangurde

Draft update to national guidelines factors in additional safeguards and makes it mandatory to establish institutional panels to review stem cell research. Gene editing would be an area of "restrictive" research.

CRISPR

Organizations working in India on stem cell research would be mandatorily required to establish an internal review committee specifically to focus on these projects and register it with a government oversight panel, under a proposed update to the country's draft National Guidelines for Stem Cell Research 2017.

The draft update builds on guidelines issued in 2013 and aims to encourage research with human stem cells while ensuring...

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More from Review Pathways

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
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US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
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US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
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Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
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More from Pathways & Standards

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
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Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.