One more new potential project for the FDA, but what this might signify is a move towards some type of standardization when it comes to the names given to a brand name drug, anyway, how it performs is more important than anything else in my opinion, so who knows where this project could go. BD
FDA is moving forward in revising the approval process for proposed proprietary brand names. Industry is worried that the changes will make the system even less predictable. Given that FDA needs industry buy-in to make the new program work, the pilot may be over before it starts. When it comes to FDA regulation, the top priority of any drug sponsor is finding predictability in the system. Sponsors want to know that if they follow a specified regulatory process, it will result in a predicable (and hopefully positive) outcome.
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