INSIGHTS | YMF Law Tokyo Japan

Biopharmaceuticals - Overview of FDA Regulatory Structure

York Faulkner

Feb 26, 20216 min read

Biopharmaceuticals - Overview of FDA Regulatory Structure

One of the fastest growing categories of new FDA filings includes applications for the approval of biological drug products, which are...

FDA Biologics License Application ("BLA")

York Faulkner

Feb 25, 20218 min read

FDA Biologics License Application ("BLA")

In contrast to regulations for new drug applications, which provide detailed explanations of the type and quality of information required...

FDA Abbreviated Biologics Application ("aBLA") for Biosimilar Products

York Faulkner

Feb 23, 20218 min read

FDA Abbreviated Biologics Application ("aBLA") for Biosimilar Products

Abbreviated Biologics Applications for biosimilar products are governed by 42 U.S.C. § 262. Section 262(k) requires an applicant seeking...

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