MEDVACON

FDA inspection and enforcement activity is moving faster, becoming more data-informed, and placing greater pressure on companies to prove control before, during, and after inspection. That matters for every biologics, cell and gene therapy, and… 

The wrong vendor does not feel expensive at first. They feel expensive when your team has to manage the work they were hired to own. When scope is unclear, schedules slip, communication is weak, deliverables… 

AI is moving into life sciences quality and manufacturing work, and FDA is showing how existing GMP expectations apply when AI is used to support regulated activities. FDA has already used enforcement to make clear… 

FDA is making one point increasingly clear. You can outsource manufacturing, but you cannot outsource oversight. That principle extends across outsourced manufacturing, testing, and critical supplier oversight. Whether the work is performed by a CDMO,… 

Quality professionals do more than most people realize. In life sciences, that work carries a responsibility that is often easiest to overlook when products are moving, milestones are being met, and problems are being prevented… 

FDA‘s March 2026 draft guidance on responding to Form 483 observations after drug CGMP inspections is worth reading closely. Not because it creates a new legally enforceable requirement. It does not. It matters because it… 

FDA’s new pilot for one day inspectional assessments is worth understanding clearly, because the actual results are more instructive than the headlines suggest. Here is what FDA reported as of late April 2026. The agency… 

FDA‘s March 2026 draft guidance on responding to Form 483 observations after drug CGMP inspections is worth reading closely. Not because it creates a new legally enforceable requirement. It does not. It matters because it… 

Here Is What the Results Show FDA’s new pilot for one day inspectional assessments is worth understanding clearly, because the actual results are more instructive than the headlines suggest. Here is what FDA reported as…