Home » Devicemakers Considering Combo Products Need to Know Drug GMPs
Devicemakers Considering Combo Products Need to Know Drug GMPs
To comply with drug-side reserve requirements, makers of single-entity combination products need to retain samples of the complete product, an expert says. That would mean inevitably you’re retaining a sample of the device as well as the drug,” said Suzanne O’Shea, a partner in the FDA practice at Faegre Baker Daniels in Indianapolis.
The GMP Letter
The GMP Letter
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