What is USFDA Purple Book? What it’s significance?
Posted on19 Nov 2019
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The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act... Read More
What is difference between 351(a) vs. 351(k) pathway?
Posted on13 Sep 2017
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351(a) is the original approval pathway for biologics. It is the pathway for approval of innovator biologics. It is also known as... Read More
What is 351(k) biologics license application (BLA)?
Posted on13 Sep 2017
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351(k) biologics license application is the biosimilar application process in USFDA. Manufacturers must submit 351(k) biologics license application (BLA) to have a product... Read More