Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Bowman Cox
FDA’s latest drug shortages task force aims to encourage investment in the reliable manufacture of generic sterile injectables that are fundamental to the practice of medicine. While the agency’s first task force continues to work with industry to avert shortages, the second will strike at underlying structural issues that cause persistent shortages of these critical medicines.
New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.
The Quality Lowdown: Novartis/Sandoz Child-Resistant Packaging; Solvent Testing; Quality Metrics; Cell And Gene Therapy
Why did Novartis/Sandoz’s hospital blister packs have to be child-resistant? Why did two warning letters to Chinese firms follow promises of more, better testing? And should firms should consider volunteering for new FDA quality metrics programs (or not) and a pre-competitive industry collaboration on cell and gene therapies?
US FDA is issuing “90-day” decisional letters at a quickening pace, publishing the inspectional results within another 30 days, and copying sponsors on warning letters, among other steps, to call their attention to GMP problems in their supply chains.
Mylan can look forward to mopping up some major cleaning validation issues a large team from FDA found during an extensive inspection of the firm’s West Virginia plant. Meanwhile, an API firm in China found it should not have left blank product release forms lying around pre-stamped “Permitted to Leave Factory.”
The Quality Lowdown: ICH Q13 and Q14, Gene Therapy CMC, Drug Shortage Gaps, And An Excipient Misstep
ICH launches continuous manufacturing and analytical procedure guidelines while US FDA promises advice on gene therapy CMC, battles drug shortages and sees what went wrong with certain eye injections.