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Summary of FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application

USA - October 24 2017 On October 13, 2017, the U.S. Food and Drug Administration (FDA) released for comment, by December 12, 2017, draft guidance for industry entitled…

WesternGeco LLC诉Ion Geophysical Corp.一案中最高法院允许追回境外使用专利的利润损失

USA - June 25 2018 2018年6月22日,美国最高法院发布一项关于追回境外使用美国专利发明之利润损失的重大裁决。具体而言,在WesternGeco LLC 诉 Ion Geophysical Corp…

Alissa K. Lipton

Summary of FDA Guidance on Statistical Approaches to Evaluate Analytical Similarity

USA - October 5 2017 On September 21, 2017, the U.S. Food and Drug Administration released a nonbinding draft guidance for industry, Statistical Approaches to Evaluate…

Jonathan R. Davies

FDA Final Guidance on Labeling for Biosimilar Products

USA - July 23 2018 On July 18, 2018, the FDA issued final guidance on “Labeling for Biosimilar Products.” The guidance provides recommendations for drafting prescribing…

Alissa K. Lipton

Summary of Final Guidance on Interchangeability of Biosimilars With Reference Products

USA - May 28 2019 On May 10, 2019, the U.S. Food and Drug Administration (FDA) released nonbinding final Guidance for Industry, Considerations in Demonstrating…

Jonathan R. Davies