New drug approval and validation strategies are needed for Fast Track, Breakthrough Therapy and Accelerated Approval drugs. A new Pharmaceutical Manufacturing article, written by Tracy TreDenick, David M. Fetterolf, and Michael Boyne of BioTechLocic, explores the challenges of and new approaches for this new era in the pharmaceutical industry. Read Article
BioTechLogic, Inc., is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization's technical, manufacturing, analytical, and regulatory resources.
Article originally published on GEN The biotechnology industry achieved many firsts this past year, from the first approved drug that can slow the rates of cognitive and functional decline in adults with Alzheimer’s disease, to the first CRISPR-based gene editing...
Originally posted on Regulatory Focus - a RAPS publication The new EU Clinical Trials Regulation represents the most significant overhaul of clinical trial requirements in Europe for a generation, and this article describes the insight gained during the months...
© 2024 BIOTECHLOGIC, INC | ALL RIGHTS RESERVED
