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.
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US FDA’s Human Drugs Program Suffers In Adjustment Of Agency Priorities
President Trump's budget request would boost compounding and vaccines by $5m, but human drugs program would lose $4.8m in training funds.
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.
FDA Announces Wide-Ranging List of Compounding Priorities for 2019
FDA has announced a multifaceted effort to tackle the oversight of drug compounding facilities this year. On the to do list: setting the groundwork for establishing centers for excellence for outsourcing facilities; finalizing a guidance on identifying insanitary conditions at drug compounding facilities, and finalizing a memorandum of understanding targeting traditional compounders that distribute an “inordinate” amount of their compounded drugs across state lines.