by Alex Zimmer | Jun 12, 2012
Check out this article, which shares data showing that FDA approves more drugs than Health Canada and the European Medicines Agency (EMA). Despite the belief that the approval process for drugs in the U.S. is rather slow, a new study published online in the New...
by Alex Zimmer | Jun 4, 2012
The Indiana chapter of RAPS presents an expert presentation entitled, “Steps to Preparing for a Successful FDA Advisory Committee Meeting!” Pearl’s own Gretchen Bowker, who is also a RAPS Fellow is the Indiana RAPS Chapter Chair. When: June 26, 2012 from 4...
by Alex Zimmer | Jun 1, 2012
Check out this article in Genetic Engineering and Biotechnology News, which does a nice job of reviewing some of FDA’s progress and shortcomings in bringing new drugs to market. They highlight a recent New England Journal of Medicine, which shows how FDA has approved...
by Alex Zimmer | May 22, 2012
The Midwest chapter of Biomedical ASQ presents the Process Validation Game! When: Thursday, May 24th, 2012 from 5:30-8 pm. Where: University of Indianapolis in the Schwitzer Student Center Building #7 Room #013 Indianapolis, IN 46227 Cost: Buffet dinner $12.50 for...
by Alex Zimmer | May 19, 2012
FDA has changed its sterility testing requirements for biological products, allowing for greater flexibility and continued improvement. Gareth MacDonald shared in a recent article in in-Pharma that with advanced technologies, patients and biologics producers benefit...
