[thewomanwithin67]

U.S. FDA CDER Home Page

If you have any questions about any drug, you can go to the FDA's site link and search for it or look them up in the drug database.

Each drug has info about their initial applications, what they're going to be used for, descriptions, strengths, if the drug has had any problems, label changes and a ton of other useful information.

This is from the FDA: (Generic Drugs: Questions and Answers)
7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.

FDA's Office of Generic Drugs (Office of Generic Drugs Home Page)

Think it's easy becoming a generic drug in America? Think again

It should not be assumed that all drug products marketed only with an established name are generic drugs: http://www.fda.gov/cder/drug/MedErrors/no_tradename.pdf

This is a sample of how Generic "inactive ingredients" are forumlated: http://www.fda.gov/cder/ogd/QbR/OGD_..._IR_Tablet.pdf
You have to have Adobe Acrobat reader to pull it up.

I was reading and found some interesting things

Electronic Orange Book Home Page

that can be added to pills, in some cases they can add 45.048% eeek! sugar or starch granules into a capsule and 254.49MG into tablets.

Isn't that what we're trying to avoid by watching what we eat?

In here also shows the different studies of Brand vs Generic forms and HOW they dissolve and how much is absorbed into the body.

Form II degrades much more quickly

than Form I, resulting in twice as much impurity RC2 as Form I

Just so you know:
What Is Bioequivalence?

Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. These tests usually involve a few hundred to a few thousand patients. Since the safety and efficacy of the brand-name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary, and would be unethical, to require that such extensive testing be repeated in human subjects for each generic drug that a firm wishes to market.

Instead, generic applicants must scientifically demonstrate that their product is bioequivalent i.e., performs in the same manner to the pioneer drug.

One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug.

The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug.

Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. Brand-name drugs are subject to the same bioequivalency tests as generics when their manufacturers reformulate them.

An FDA Slideshow that's pretty cool: What You Want to Know About Generic Drugs

My main question/concern is what about the "inactive" ingredients. I still can't find testing or research on the specifics of HOW the inactive ingredients affect us as the consumer or if there is regulation as to what all can be put in generic formulations....