Watch the gene therapy webinar now!
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| | | | | | | Hi Colleague, It has been a big year for gene therapy--several gene therapy products received approval from FDA, and in July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy. The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products.
This on demand webinar: |
| | Reviews Commissioner Gottlieb’s statement Provides an overview of the six guidance documents Discusses the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development |
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