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Other Barks & Bites for Friday, June 16: Republican Senators Introduce No Free TRIPS Bill, Synopsys Wins Trade Secrets Case at Fourth Circuit and Second VLSI Patent Nixed by PTAB - IPWatchdog.com

Published: June 19, 2023

This week in Other Barks & Bites: Music publishers launch a copyright infringement lawsuit against Twitter; Korean authorities arrest a former executive for attempting to replicate a copy of a semiconductor manufacturing facility; three Republican senators introduce a bill attempting to tie President Biden’s hands on TRIPS waivers; and the U.S. Court of Appeals for the Fourth Circuit vindicates Synopsys…

Source: ipwatchdog.com

Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination

Published: June 12, 2023

FDA is issuing this guidance to help tattoo ink manufacturers and distributors recognize situations in which a tattoo ink may become contaminated with microorganisms, and thus, be potentially injurious to health.

Source: fda.gov

CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting

Published: June 7, 2023

This guidance describes an approach to show bioequivalence for generic Type A medicated articles containing poorly soluble, locally acting, APIs that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate bioequivalence.

Source: fda.gov