RichyBerlin : FDA
FDA Finalizes 6 Gene Therapy Guidances, Unveils a New Draft
Posted 28 January 2020 | By Zachary Brennan
"The US Food and Drug Administration (FDA) on Tuesday finalized six guidance documents on gene therapy development and released a new draft guidance on interpreting the sameness of gene therapies under the orphan drug regulations.
The guidance release comes as more than 900 investigational new drug applications are ongoing for gene and cell therapy clinical studies, and as FDA has struggled to hire enough experts to tackle the related challenges...."