Biosimilarity: The FDA Perspective CRC Press | English | 2019| ISBN-10: 1498750397 | 436 pages | PDF | 18.06 MB
by Sarfaraz K. Niazi (Author) The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place
Fight for Your Health: Exposing the FDA's Betrayal of America (Take Charge (Truth in Wellness)) By Byron J Richards 2006 | 280 Pages | ISBN: 1933927178 | PDF | 10 MB
Navigating the FDA Regulatory Processes: An Integrated Clinical and Engineering Approach English | 2025 | ISBN: 1482207087 | 262 Pages | PDF EPUB (True) | 15 MB
FDA and Worldwide Quality System Requirements Guidebook for Medical Devices By Daniel, Amiram; Kimmelman, Ed 2008 | 324 Pages | ISBN: 0080461042 | PDF | 5 MB
Douglas J. Pisano, David S. Mantus, "FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, 2nd Edition " 2008 | ISBN-10: 1420073540 | 464 pages | PDF | 8 MB
FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies by Holly Fernandez Lynch, I. Glenn Cohen English | September 8, 2015 | ISBN: 0231171188 | 568 pages | PDF | 2.64 Mb