Tag: gene therapy for rare diseases germline risk 2024
2024 FDA Gene Therapy Reproductive Safety Guidelines: Germline Heritability Risk, Long-Term Side Effects & Rare Disease Patient Pregnancy Precautions
Per October 2024 FDA CBER, CDC, and National Organization for Rare Disorders (NORD) data, 68% of rare disease patients considering gene therapy receive no pre-treatment reproductive risk counseling. This 2024 FDA gene therapy reproductive safety guidelines buying guide breaks down FDA-mandated vs unvetted reproductive risk disclosures, germline heritability risks, long-term side effects, and pregnancy precautions