Page 7 - Submit Comments News Today

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…

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.

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.

E6(R3) GOOD CLINICAL PRACTICE (GCP)

Draft Guidance Clinical / Medical

Migraine: Developing Drugs for Preventive Treatment

Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products; Draft Guidance for Industry; Availability

Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information

Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations

Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act