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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

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
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United statesSouth koreaSouth koreanKathi vidalYoung liuYoon suk yeolTommy tubervilleJerome powellHouse committee on scienceAppeals court affirms synopsys trade secrets victoryNational music publisher associationUs courtNational science foundationSamsung electronicsDepartment of energyFederal reserve

Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination

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.

United statesDrug administrationGuidance issuing officeSubmit commentsFood safetyFederal foodCosmetic act

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

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.

Guidance issuing officeDrug administrationSubmit comments

E6(R3) GOOD CLINICAL PRACTICE (GCP)

E6(R3) GOOD CLINICAL PRACTICE (GCP)

Guidance issuing officeDrug administrationSubmit commentsDrug evaluationBiologics evaluationGood clinical practiceInternational councilTechnical requirementsHuman use

Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment

Draft Guidance Clinical / Medical

Drug development programs for treatmentDrug administrationGuidance issuing officeSubmit commentsDrug evaluationBladder pain syndromeEstablishing drug development programsEstablishing effectiveness