Pearls of Wisdom
FDA updates testing requirements for evaluating the preclinical safety evaluation of biotech pharma products
In May 2012, FDA recently updated its requirements under ICH S6 Guidance for its preclinical testing of biotech drugs. To view this amendment, click here. Along with notable advances and the need to harmonize with international standards, the amendment states that its...
Don’t miss this PDA event!
The Parenteral Drug Association (PDA) invites you to their 2012 Innovation & Best Practices on Sterile Technology Conference entitled Sterility Assurance for Aseptic Processes and Terminal Sterilization. When: June 18-19, 2012 Where: Conrad Chicago in Chicago,...
Study shows U.S. approves more drugs than Europe and Canada
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...
Tuesday, June 26th–RAPS Indiana chapter holds next meeting
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 - 6:30 pm...
Several reports bring mixed view on FDA’s ability to bring drugs to market
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...