Connect with us

Medical

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA – 02/24/2022 – 02/24/2022

Avatar

Published

on

Medical

Collecting and Providing 702(b) Portions of FDA Official Samples

Avatar

Published

on

By

Collecting and Providing 702(b) Portions of FDA Official Samples – Questions and Answers

Original Source: fda.gov

Continue Reading

Medical

FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers – 03/23/2022

Avatar

Published

on

By

The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 1-3 PM (EST) entitled “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology to identify areas of conceptual

Original Source: fda.gov

Continue Reading

Medical

FDA Takes Actions to Expand Use of Treatment for Outpatients With Mild-to-Moderate COVID-19

Avatar

Published

on

By

The FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease in places such as skilled nursing facilities, home healthcare settings and outpatient facilities.

Source: fda.gov

Continue Reading

Trending

WVPU.com