5 Steps for Developing and Managing Supplier Quality Programs
With the increased pressures of cost control for manufacturers of FDA-regulated products and the rapid expansion of globalization of the supply chain, the expectations of manufacturers and sponsors...
FDA Shelf Life Extension Program (SLEP)
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...
Citing the IIG as Evidence of Ingredient Safety Comes with Caveats
It has become common practice in developing drug formulations to consult the FDA's Inactive Ingredient Guide (IIG) to obtain information on "acceptable levels" of excipients used in previously...