Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies
By Zachary Brennan -
Published 11 September 2017
FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices
Tags: Scott Gottlieb, FDA commissioner, clinical development
Early Biosimilar Development: A Model for Expeditious Progress to a Phase 3 Trial
By Raymond Huml, MS, DVM, RAC, Nigel Rulewski, MD, Kamali Chance, MPH, PhD, RAC, Doris Weilert, PhD, J. Rick Turner, PhD -
Published 01 March 2016
This article discusses biosimilar clinical development and how companies are addressing the clinical development concerns associated with early biosimilar drug development.
Categories: Features, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy
Tags: Biosimilars, Clinical development, CMC
EMA Drafts New Clinical Development Guideline for Fixed Dose Combination Drugs
By Michael Mezher -
Published 13 May 2015
In response to a rise in the use of fixed dose combination (FDC) drugs, the European Medicines Agency (EMA) has revised its guideline addressing the clinical development requirements for FDCs.
Categories: News, Europe, EMA, Active pharmaceutical ingredients, Clinical, Drugs
Tags: Fixed dose combinations, FDC, drug-drug interaction, clinical development