Regulatory Sciences
Innovation vs. Safety: Another Definition for the “Chicken or the Egg"
We all know that the FDA’s mission is to promote and protect public health. However, in their effort to protect the public health, it seems that they may be inadvertently harming the industry that...
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...
Regulatory Sciences
Competition Between Orphan Drug Sponsors – Good for Patients, Strategic Complexities for Sponsors
The regulations developed by the FDA for implementing the Orphan Drug Act contain a number of features that are intended to maximize benefits to the orphan disease patient population, but which pose...