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Parents of ADHD Children

Is this a chance to comment to FDA on bioequivalency?

I’d like others to check this government link. Is this an opportunity to comment on a petition to change bioequivalence metrics so extended release methylphenidate drugs have to have the same release timing to be generics?!docketDetail;D=FDA-2004-P-0151

There are several documents on the page with technical and legal information.

If you have experienced any difference between the “generic” Concerta manufacturers, this is important.

There are several documents on that page that probably should be looked at as they discuss the appropriateness of particular metrics. One of them has a “live” comment button!

I’m pretty good at reading this kind of information, but am hoping someone else can provide their take on what this is about. If this is really a chance to comment - we should spread the word.


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