06 24 21 -- FDA s Codifies New Chemical Entity Designations Approach pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.
04.20.21 FDA Inspections: Are Changes On The Horizon?
To get the most out of data, you must ensure they are findable, accessible, interoperable, and reusable F.A.I.R. for short. Organizations simply don’t have the infrastructure in place to be able to capture data with context and then store them so that they can be searched and accessed with ease. We’ll explore how you can change that using the F.A.I.R. principles, which have been recognized as standards to enable for that potential to be realized.
Featured Editorial
By Kalah Auchincloss, Greenleaf Health, Inc.
A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the c
03.09.21 Incorporating Excipients Into QbD Studies For Drug Development An Introduction
Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.
Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!
By Brian Carlin (DFE Pharma), Chris Moreton (FinnBrit Consulting), Dave Schoneker (Black Diamond Consulting), Katherine Ulman (KLU Consulting), and Joseph Zeleznik (IMCD)
This article is the first in a three-part series based on information from the new guide, “Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design,” published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the impact of excipient variabili
02.23.21 Cleaning Of Multipurpose API Plants: 9 Rules To Follow
Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.
Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!
By Grant Mordue
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an API plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.