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Bowman Cox
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Latest From Bowman Cox
The Quality Lowdown: Foreign Burden, Border Destruction, Particles, Sterility
FDA asks about regulating foreign firms more and destroying drugs at the border, and questions firms about particles and aseptic practices.
The Quality Lowdown: What Inopak, Dong Juan And Sofex Must Do To Comply
In this week's must-read Quality Lowdown: A New Jersey firm must investigate antibacterial foam that wasn’t, a Chinese firm must validate its OTC spray, a Portuguese firm must establish a quality system, and FDA must get forensic help if it is to understand certain drug-related deaths.
How Coherus Overcame FDA’s Doubts About Udenyca Immunogenicity
Better immunogenicity assays overcame concerns raised in complete response letter for Udenyca, leading to approval of the Neulasta biosimilar.
The Quality Lowdown: No Excuses For Homeopathic, CMO, OTC Quality Failures
US FDA assigns blame for quality failures at mostly US-based homeopathic, contract manufacturing and OTC firms, while WHO approves growing manufacturing plant in Kenya.
US FDA Budget Boost Would Increase Domestic Drug Manufacturing By Better Regulating New Technologies
FDA’s fiscal year 2020 budget request calls for spending on figuring out how to regulate new drug manufacturing technologies under the rubric of increasing US domestic manufacturing.
FDA Again Proposes To Advance Outsourcing Sector With Center Of Excellence
The US FDA’s FY 2020 budget request calls for funding to help advance the emerging drug compounding outsourcing sector, as did the FY 2019 request. The money would bring more training, specially tailored GMP requirements and a center of excellence.