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Food and Drug Administration (FDA) Revision of USP Chapter on Gene Therapy Medicinal Products (Catapult’s regulatory round-up – October 2024)

Year: 2024

Type: other

Abstract: This chapter covers the clinical applications, manufacturing processes and analytical methods of gene therapy products, which are constantly evolving. The current amendment proposals include, for example, the following points: Delete the reference to "Safety Tests-Biologicals" in "Biological Reactivity Tests, in vivo" from the chapter Delete the Safety Tests-Biologicals section from Chapter <88>, as the corresponding FDA Code of Federal Regulations, 21 CFR §610.11, was revoked on August 3, 2015....</88>

Source: Industrias Culturais (Universidade de Coimbra)

DOI: 10.58079/12ps5

Author: Adelage

Language: English

Topic: Virus-based gene therapy research

Subfield: Genetics

Field: Biochemistry, Genetics and Molecular Biology

Domain: Life Sciences

Open Access status: green

OpenAlex ID: W6899048900

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