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FDA Biologics License Application ("BLA")

York Faulkner

2021年3月1日読了時間: 8分

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

2021年2月28日読了時間: 8分

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...

Patent Disputes Regarding Biosimilar & Interchangeable Biological Products

York Faulkner

2021年2月27日読了時間: 9分

Patent Disputes Regarding Biosimilar & Interchangeable Biological Products

As an overview, the patent dispute resolution procedures under the Biologics Act include (1) the confidential disclosure of the aBLA...

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