For me and most other medical translation professionals, 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.
Why is this significant? This second path allows a developer to come up with a new approach for a previously approved drug, while using the original clinical data. This is a huge benefit. The cost and time are radically reduced.
The third path for submissions is for generics. Generics have an abbreviated process for approval (called the ANDA versus the NDA). A generic manufacturer only needs to complete studies that demonstrate the generic product to be bioequivalent to the original product. Again, this is a major time and money saver.
This new understanding will better prepare me for my work with our clients. Our clients have clinical and submission needs, and they come to us to help them through it. In my seven years at ForeignExchange, I have helped many. This article will be another bit of knowledge to help me down that path.
You can read the full article here: http://www.cedrugstorenews.com/userapp//lessons/page_view_ui.cfm?lessonuid=&pageid=D5B9DCC03556C28694B51161244B36F9.
Entry by Bob Muzerall
Learn how ForeignExchange Translations helps drug and device companies conduct clinical trials in countries around the world.
Categories: clinical research