Dec 7, 2018· Comment from Parenteral Drug Association (PDA)· FDA-1999-D-0081-0046
PDA appreciates FDAs efforts to further clarify its thinking with respect to testing of retroviral vector-based human gene therapy products for replication competent retrovirus during product manufacture and patient follow-up. PDA is pleased to provide additional comments and recommendations for consideration. PDA is a non-profit international professional association of more than 10,000 individual member scientists having an interest in the fields of pharmaceutical, biological, and device manufacturing and quality. Our comments were prepared by a committee of experts with experience in the practice of pharmacy as well as members representing our Biopharmaceutical Advisory Board and Board of Directors.