I read an interesting article recently entitled, "Understanding the 505(b)(2) Approval Process." What I found most interesting was the clear and concise explanation of the clinical trial and the submission processes for the FDA. The clinical trial process is not new to me. I've been working with clients to help them with this work for over 10 years. Part of the submission section was new to me.
The basics of the submission process are clear. However, I did not know that there were three separate paths a company could pursue, based on their product – the main one is 505(b)(1). This path is for new drugs. The second one is 505(b)(2). This is for drugs that are not completely new products, yet they are not generics. Drugs chosen for this path may have the same active ingredients as a previously approved drug, but now the drug is formulated in a different delivery mechanism or with a different indication.
For More Information please click here: Understanding submissions
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