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FDA Draft Guidance on Evaluation of Therapeutic Equivalence

USA - August 4 2022 On July 21, 2022, the FDA issued draft guidance titled “Evaluation of Therapeutic Equivalence.” In this guidance, the FDA explains therapeutic…

Marcelo Barros, Jeffrey D. Smyth

Final FDA Guidance on Safety Considerations for Medication Container Labels and Carton Labeling

USA - June 10 2022 On May 18, 2022, the FDA issued final guidance entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication…

Jessica L. Roberts Ph.D., Jeffrey D. Smyth

Driving Forward: The Automotive Tech Fuelling IP Interests

USA - April 5 2022 Automobiles are many things to many people. At their heart, they're a core mode of transportation that ferry passengers to and from places, including…

Kevin D. Rodkey, Kara A. Specht

The Road Ahead - IP Challenges in the Automotive Industry

USA - February 9 2022 Since the automobile became a primary mode of transportation, emerging Technologies and ensuing consumer demands have redefined the way vehicles are…

Anthony D. Del Monaco, Kara A. Specht

FDA Final Guidance on Enhancing the Diversity of Clinical Trial Populations

USA - November 19 2020 On November 9, 2020, FDA issued final guidance on “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices…