Clinical Research Solutions

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...