Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for ...
The US Food and Drug Administration (FDA) on Thursday finalized its guidance on the use of alternative tools for conducting preapproval inspections (PAI) or prelicense inspections (PLIs) in lieu of ...
In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...
Guide highlights key compliance scenarios—from FDA actions to global expansion—where consulting is essential. IRVINE, CA, UNITED STATES, April 1, 2026 ...
Risk management is a major emphasis of FDA’s new compliance program, the Quality Management System Regulation (QMSR), and companies should expect to see big differences in how the agency will conduct ...
IRVINE, CA, UNITED STATES, April 1, 2026 / EINPresswire.com / — Qalitex Laboratories, an ISO 17025-accredited analytical testing laboratory serving supplement and pharmaceutical brands across North ...
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