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FDA Releases Draft Guidance On CMC For Individualized ASO Therapies
A new FDA guidance released in Dec. 2021 acknowledges the difficulties inherent in manufacturing individualized antisense oligonucleotide (ASO).
Brown rudnick
Neil dispirito
Adamm schoen
Williamf kiesman
Xiulong shen
Robert simler
Benjamin andrews
Robertb ruh
Syminj charpentier
Drug administration
Nucleic acids research
European pharma oligonucleotide consortium
Controls recommendations
Guidance for
Severely debilitating
Life threatening diseases
FDA Releases Draft Guidance On Clinical Recommendations For N of 1 Gene Therapies
To eliminate ineffectiveness due to genetic differences, clinical trials of individual patients, described as an “N of 1”.
United states
Jacobj adashek
Kari oakes
Peter marks
Brown rudnick
Hans georg eichler
Janet woodcock
Eric topol
Neil dispirito
Adamm schoen
Nicholasj schork
Elizabeth lillie
Robertb ruh
Debabrata mukherjee
Syminj charpentier
Jane nikles
FDA Releases Draft Guidance On Clinical Recommendations For N of 1 Gene Therapies
To eliminate ineffectiveness due to genetic differences, clinical trials of individual patients, described as an “N of 1”.
United states
Jacobj adashek
Kari oakes
Peter marks
Brown rudnick
Hans georg eichler
Janet woodcock
Eric topol
Neil dispirito
Adamm schoen
Nicholasj schork
Elizabeth lillie
Robertb ruh
Debabrata mukherjee
Syminj charpentier
Jane nikles
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