Brands vs. Generics

As a physician with over 30 years in the drug development and regulatory industry, I think the doctors and patients advising you may not truly understand the drug development process (and most really don’t, unfortunately). The FDAs Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research requires generic drugs to go through the same rigorous manufacturing process as non-generic drugs (and sometimes only bioequivalence studies showing similiar pharmacokinetic effects are allowed). Unfortunately, they have no control over drugs purchased online from foreign countries or bought in foreign countries (under the regulatory authority of those regions) – and the language of your blog writer above makes me wonder if this is the case (“Japanese generic”). Of course, a foreign company can also seek regulatory approval in the US, but I suspect this is not the case here.

What this writer is saying is important. You must know the source of your drugs if you do not buy them from a known, approved pharmacy.

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