Blog
Early communication strategies for FDA approval
Check out this article which discusses some strategies to better communicate with regulatory agencies in the preclinical stage of drug approval. Some of the major themes highlighted are to stay consistent and accurate when discussing your product, think twice about...
How patient advocacy groups are playing an ever increasing role in finding their own cures
With all of the online resources and growing social media outlets, many patients are finding it easier than ever to “self-diagnose,” or at least come up with something that they think is the answer for their ailments. It is also easier now to find patient support...
Tuesday, June 26th–RAPS presents expert presentation!
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, RAC, FRAPS is the Indiana RAPS Chapter Chair. When: June 26, 2012 from 4 - 6:30 pm Where: Indiana...
Clinical research results now to be more transparent
Due to a “credibility gap”, drugmakers are now being moved to make reports on clinical research results more transparent, whether the results are good or bad. According to an article on mednews.com by Kevin B. O’Reilly, there have been 10 approved recommendations on...
ACRO presents “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice” at FDA Hearing
During an April 23rd FDA hearing to gather input on ways to modernize the clinical research process, The Association of Clinical Research Organizations (ACRO) provided FDA a number of suggestions to improve the drug development process. ACRO’s main suggestion was to...