Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

Strong HACCP Training Supports More Effective FDA and USDA Inspections

Industry leaders emphasize that structured HACCP training strengthens compliance, streamlines FDA, USDA & FSIS ...
Morning Call PA

Nearly 2,000 drug manufacturing plants are overdue for FDA inspections after COVID delays, AP finds

WASHINGTON (AP) — Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory ...
Homeland Security Today

COVID-19 Complicates Already Challenged FDA Foreign Inspection Program, Says GAO

An FDA investigator prepares a test sample for IMS analysis from a shipment of dietary supplements that arrived at the Port of Buffalo in Buffalo, N.Y. (FDA photo) The outbreak of COVID-19 has called ...