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Moreshwar (Moru) B.Vaze, PH.D

Duane Morris LLP

Articles

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What Your Competitors Don’t Know Can Hurt You - The Supreme Court Rules that Secret Sales Can Trigger the On-Sale Bar Under the AIA

USA - January 24 2019 The Supreme Court of the United States recently affirmed the decision of the U.S. Court of Appeals for the Federal Circuit in Helsinn Healthcare v...

Jonathan Lourie, Vicki G. Norton, Ph.D., Matthew C. Mousley.

FDA Issues Final Guidance on Data Integrity and Compliance with Drug CGMP

USA - January 14 2019 Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data...

Frederick R. Ball, Carolyn A. Alenci.

FDA Announces New UDI Compliance Deadlines via Another Guidance Document

USA - December 27 2018 On September 24, 2013, the Food and Drug Administration (FDA) issued a “final” rule regarding the Unique Device Identification System to adequately...

Frederick R. Ball, Carolyn A. Alenci.