Newsletter - November 21, 2024
FDA’s Comprehensive Advice for Cell and Gene Therapy Product Development
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...Read More
GAO Report Highlights Keys Issues with FDA Audits
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 concerns about FDA auditing practices over the years. GAO’s latest report highlights a practical issue...Read More
FDA’s Comprehensive Advice for Cell and Gene Therapy Product Development
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...Read More
GAO Report Highlights Keys Issues with FDA Audits
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 concerns about FDA auditing practices over the years. GAO’s latest report highlights a practical issue...Read More
