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Latest From Bowman Cox
FDA asks about regulating foreign firms more and destroying drugs at the border, and questions firms about particles and aseptic practices.
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.
Better immunogenicity assays overcame concerns raised in complete response letter for Udenyca, leading to approval of the Neulasta biosimilar.
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.
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.