Gretchen Bowker’s Article Published in ACRP Monitor
Gretchen Bowker’s co-authored article, along with Dr. Craig Caldwell, Human Protection: Not Just an Obligation, A Career, was published in the September 2011 issue of the ACRP Monitor. The article begins on page 21 and to view the online version of the article, go here.
Drugmakers Receive Extended Deadline
Drugmakers are now required to record all payments and gifts, including dinners, rounds of golf and consulting fees, to doctors. The Physician Payment Sunshine Act is part of President Obama’s reform of the health care system. The extension is due to the proposed rule remaining unpublished so drugmakers will now have until the final rule is published in 2012 to be required to record the payments. To read the story on Reuters, go here.
FDA Released Two New Guidance Documents
The FDA released two new documents aimed to clarify the process for clinical trial approval and establishing earlier clinical trial studies during device development. The FDA is currently searching for a small number of companies to in the pilot program. Jeffery Shuren, director of the FDA’s CDRH, stated that earlier studies in investigational devices will expedite the process and get the device to the market sooner as well as spur innovation. At Pearl IRB, we have noticed an increase in FDA requirements for clinical trials for 501k products, even those who’s predicates have not been asked to do clinical trials previously.
The first document, FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, can be found here and the second document, Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies, can be found here.
Pearl CEO Guest Expert for WBEC Webinar
Pearl Pathways’ President and CEO, Diana Caldwell, will be a guest expert for the Women’s Business Enterprise Council of the Great Lakes region (WBEC-GL) webinar on December 7th at 12pm. The subject of the webinar will be focused on how to get the most out of a WBEC certification including learning the best business practices and cultivating corporate relationships. To access the webinar, go here. It is suggested to access the site 15 minutes before the webinar begins to avoid allow time to address any complications.
Pearl COO Bowker to Lead Discussion on December 1st
Pearl Pathways’ co-founder and COO, Gretchen Miller Bowker, will be leading a discussion presented by ASQ Biomedical Division covering the similarities and differences between INDs and IDEs and everything in between. The discussion will be held at the University of Indianapolis in the Schwitzer Student Center on Thursday December 1, 2011 from 5:30pm to 8:00pm. To find out more information or to sign up for the dinner and discussion, click here.
Senators Look to Spur Innovation & Get Products to Market Faster
A group of bipartisan senators introduced a plan to streamline the FDA‘s regulation that would speed up the process of taking innovations to the market and encourage innovation. The bill would also focus on restoring balance to the conflict of interest requirements within the FDA. With the rules in place now to reduce industry ties in advisory committees, complications and delays can arise. The bill aims to ease strict rules on conflict of interest that can cause delays.
To read the full article from Policy and Medicine, go here or you can read “Medical Device Regulatory Improvement Act” in its entirety.
Save the Date for Indiana CTSI Annual Meeting
The fourth annual Indiana CTSI meeting will be held May 7th 2012, at the University Place Conference Center and Hotel at IUPUI. The meeting will offer a platform to hear from researchers, view presentations and network with professionals. Save the date on your 2012 calendar. To learn more, go here.
QbD Model for Clinical Trials Could Cut Costs
The FDA is working on developing a quality-by-design (QbD) model for clinical trials that would cut monitoring costs. The plan is to implement the model within the next 25 years. There is already a QbD model is place for manufacturing that allows for the quality production each and every time and that is what the FDA is searching for with clinical trials. The push for a new model to monitor clinical trials is to develop a better infrastructure for how the trails are regulated and conducted. To read more about this topic, go here.
Mistrust Leads to Decrease in Volunteer Participation
Recently at a conference held by the Institute of Medicine (IOM), low participation in new clinical trials and research were discussed between industry professionals. One viewpoint states mistrust of clinical trials, science in general and the motives of the industry are hindering recruitment. Gaining the public’s trust and providing results could be the key to increasing participation. To read more, go here.
National Center for Advancing Translational Science Launch Delayed
The National Center for Advancing Translational Sciences is a research center focused on expediting the process from breakthroughs in the lab to the clinic. Opening of the center has been delayed by funding from the government, with no clear decision in site. The foundation has developed a Plan B that would allow the center to launch under a reduced budget. Dr. Francis Collins, director of the NIH, has made it a personal goal to open the facility in time for him to run the center for the first fiscal year. The problems for the center have become lost in the process as a split congress focuses on more pressing budget issues. To read more, go here.
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