by Matt Foor | Mar 23, 2012
Fifteen years ago the FDA set out to control cGMP labeling (Current Good Manufacturing Practice). The FDA first began its efforts to fix cGMP labeling in 1993 and eventually proposed a rule in 1997. The goal of its current final rule is to narrow the scope of its...
by Matt Foor | Mar 6, 2012
Join us for a lively presentation with Dr. Lois Frankel on March 13, 2012 from 5:00-8:00PM. This presentation is sponsored by Roche Diagnostics and the HBA Indiana Chapter. Dr. Frankel is a bestselling author who focuses on helping women get the most they want from...
by Matt Foor | Mar 6, 2012
Please save the date for the FDA 101 Regulatory Conference which will be held on May 23, 2012. This will be a day long event held in Indianapolis, Indiana and will feature expert speakers from the industry.
by Matt Foor | Mar 1, 2012
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has warned inspectors that job cuts at manufacturing sites may lead to a shift in lower quality and even compliance issues later on. The PIC/S has also urged regulators to use job cuts as a factor in risk-based...
by Matt Foor | Feb 23, 2012
Long awaited FDA guidance on biosimilars is here. The FDA recently released three documents outlining their thoughts on biosimilars and the use of alternative drug delivery systems. Using alternative devices could potentially provide biosimilar developers an advantage...
