general regulatory

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...

Clinical Research Solutions

Food and Cosmetic Ingredients that are also Excipients in Drug Products – OGD Policy

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

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...

Clinical Research Solutions

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...

Clinical Research Solutions

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...

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