Search Results for clinical development

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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