Update of regulation on cell and gene therapy to keep up with changes in the U.S.A. industrial secto

05/08/2020
          From 2018 until the beginning of 2019, the United States Food and Drug Agency (FDA) announced eight recommended guidelines in cell and gene therapy. The guidelines helped the regulatory body keep up with changes in the industry and create a regulatory landscape in the field of cells and gene therapy in response to the rapid development of the industry and the common interests of the industry and patients.

          Over the past two years, the rapid improvement in product development included production process consistency, quality maintenance, as well as increased production at a lower cost. Most importantly, the guidelines highlighted the application of data analytics in product quality analysis, patients’ time-series data analysis, increased inspection and review for medical treatment precision. This development trend prompted the collection of knowledge and experience in the industry. Were there mutual cooperation between the manufacturers and regulators, the legislation of new regulations supporting industrial investment, better product standards in medical treatments for diseases, such as cancer and genetic disorders, e.g., cystic fibrosis.
 
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