Read expert advice on how to implement FDA’s rule on current Good Manufacturing Practices for combination products. Mary C. Getz, PhD, Olivia Wong, D. Michelle Garrett, and W. Ben Shand In January ...
Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
New opportunities to develop innovative — and often complex — products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should ...