Clinical Research Solutions
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...
Clinical Research Solutions
In a recent teleconference with senior officials in the Office of Generic Drugs (OGD) at the FDA, it was conveyed that it is the policy of OGD in determining the safety of excipients to rely...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...