Resources

Although cell and gene therapy (CGT) products that treat previously untreatable diseases are being approved, manufacturing these products can be challenging.Cell therapy manufacturing uses living cells, so stability can be an issue for both source materials and final products. Frequently the shelf life of these products is just a few hours.This presents logistical issues, including […]

In recent years, significant data integrity lapses have occurred at global pharmaceutical, biotechnology, and medical device firms.  Repercussions have included new products not being approved, rescinded approval of products on the market, closure of manufacturing plants, massive product recalls, FDA import alerts, and drug shortages. At the same time, data is proving crucial to advancing […]

Highlights of FDA’s Center for Veterinary Medicine (CVM) activities in FY 2020 include: Releasing a draft guidance for industry on Compounding Animal Drugs from Bulk Drug SubstancesManaging animal drug shortages, implementing a new system that enables U.S. exporters of animal food, drugs, and devices to apply for and obtain various types of export certificates onlineCompleting […]

Warning letter enforcement was sparse again this week—many warning letters to firms promoting COVID diagnostics or treatments, that continues unabated. FDA posted one warning letter to an OTC pharmaceutical firm, but none to device, pharmacy, or outsourcing firms. CBER issued one untitled letter to a firm that markets cellular products from the umbilical cord or […]

FDA’s Quality Metrics Initiative, announced in April 2013 to help promote “quality-driven corporate culture” in drug and biologics manufacturing, has been slow in coming to fruition. However, itsQuality Metrics Site Visit and Feedback Programs that began in earnest in 2019 may help breathe life back into that effort. Find out more about what participants in […]