JG BioConsult, LLC

CMC, GMP and Quality Consulting for the Biotech Industry

New FDA GT Draft Guidance

FDA has published a new draft guidance for industry titled “Human Gene Therapy for Neurodegenerative Diseases Draft Guidance for Industry January 2021” providing sponsors with information regarding new gene therapies for neurodegenerative diseases. The guidance is available on the FDA Website in PDF format here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-gene-therapy-neurodegenerative-diseases

The comment period is currently open and comments can be submitted using the above link.

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