Day: November 21, 2024

The number of cell and gene therapy (CGT) products has increased steadily over the last decade using traditional product development guidance documents. Although the FDA has released about 37 guidance documents governing the requirements for these products, developers frequently need additional help to define the specific non-clinical, clinical, and manufacturing requirements. A new FDA Guidance … Read more

The FDA’s audits or inspections of manufacturing facilities are critical to ensuring the availability of high-quality regulated products to US consumers. The Government Accountability Office (GAO) has raised issues with FDA auditing practices over the years. GAO’s latest report highlights a practical reason that may be affecting FDA audits: the cadre of its inspectors.  FDA … Read more