Diabetes Testing Devices-FDA Releases New Guidance Documents

 

Alexander Gaffney of raps.org details the Food and Drug Administration’s (FDA) push for new development approaches for diabetes testing systems.  FDA has typically not distinguished between prescription and non-prescription diabetes testing devices.  In review of the guidance documents, it is clear that FDA wishes to address concerns regarding the potential sharing of devices, as well as cleanliness. To view Gaffney’s article, click here.  To help address these concerns, FDA released two new separate draft guidances on January 6, 2014.  To see both guidance documents, see the links below:

 

 

 

All comments are due April 6, 2014.  Need help with your diabetes testing device or diagnostic, contact us at contact@pearlpathways.com.

Pearl Pathways’ website gets an update

Pearl Pathways’ website has recently seen a few upgrades in content. The News & Events section now provides a easy to read layout, two new pharmaceutical and one new medical device Case Studies have been added, and several of the Services pages have been updated to include more detailed descriptions of the breadth of our service offerings. Check out the changes at pearlpathways.com.

IHIF May Lunch Series Addresses Crowdfunding

The IHIF May lunch series features Dr. Samuel P. Wertheimer, managing director at Poliwogg, an online marketplace for early investments, and Marcus Chandler, partner and Barnes & Thornburg LLP.  They will be sharing professional insight about the budding crowdfunding investment strategy. The focus will be discussing legal, accounting, and business strategies specifically for bioscience commercialization projects.

Topic: “Crowdfunding for the Life Sciences”

When: Tuesday, May 21,2013

Registration: 11:30 – 12:00 PM

Presentation: 12:00 – 1:00 PM

Location: Barnes and Thornburg LLP, 11 S. Meridian St., Indianapolis, IN

For more information and registration click here.

For other information about bioscience startups visit Pearlpathways.com or call (317) 899-9341

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Pearl partners with Hoosiers Work for Health

Pearl Pathways has partnered with the Hoosiers Work for Health coalition. Hoosiers Work for Health is the Indiana chapter of a national initiative that unites health consumers, biopharmaceutical company employees, vendors, suppliers and other business and community partners to showcase the importance of the life sciences industry on the Indiana economy and on the quality of health for Hoosiers. Partners include local chambers of commerce and research centers, labor, businesses, patient advocacy organizations, provider groups and biopharmaceutical research companies that work together to improve America’s health care system and strengthen our economy. For more information, visit www.hoosiersworkforhealth.org

INpact Meeting: February 21, 2013

Join medical device professionals at the February INpact meeting for pizza and local beer.

What: INpact Medical Startup Meetup

When:  Thursday, February 21, 2013 at 5:30pm

Where:  Speak Easy, 5255 Winthrop Avenue, Indianapolis, IN

Price: $15

For more information and to register, click here.

 

 

Save the Date: Gretchen Bowker, Pearl COO to speak at MAGI’s Clinical Research Conference, Boston, May 5-8

This year’s MAGI Clinical Research Conference will take place May 5-8 in Boston, Masssachusettes. Pearl’s Gretchen Bowker will be presenting “Medical Device Regulations: How device and drug regulations and guidances differ” during the Regulatory Compliance session on Tuesday, May 7, 2013 from 1:30-2:30.

Pearl will also be exhibiting on the floor so please stop by and see us! A special discount code (GP188) is offered to all Pearl clients and contacts. To learn more, check out the MAGI conference website.

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Insight on the Potential Impact of Standardized Clinical Data Terminology on Clinical Studies

In a recent article in Applied Clinical Trails Online, author Wayne Kubick describes the changes that could occur in conducting future clinical trials.  Kubick highlights Prescription Drug User Fee Act (PDUFA V), which calls upon the FDA to establish a standardized clinical data terminology in an effort to improve pre-market analysis and safety signal detection.  This regulatory improvement could provide more consistent communications between current and future clinical researchers.  The requirement is projected to impact the entire clinical research community. Various open standards development organizations, such as the Clinical Data Interchange Standards Consortium (CDISC) and its joint partnerships are actively participating in the initiative, as well.

In the article, Kubick examines the current inconsistencies among current clinical studies, and then proceeds to discuss the challenges in developing standards in therapeutic studies, such as gathering a consensus among researchers for definitions of key concepts and terms in the area. He proposes an online reference database/repository for the management of the therapeutic standard documents that is fully accessible to entire research community. Kubick further highlights the multiple advantages to creating information resources for therapeutic studies, such enhanced research efficiency and quality of data.  To read the full article, click here.


AvaMed maintains optimism in repealing medical device excise tax

AvaMed hopes to secure enough Congressional support to repeal the 2.3% medical excise tax before implementation on January 1. AvaMed plans to reiterate the negative effects of the policy to the industry and capitalize on any opportunities to challenge the tax. In a recent article by Fierce Medical Devices, the device tax has become increasingly complicated as “companies including Welch Allyn have already slashed jobs or retrenched from expansion plans” stating the tax was to blame.

To read the full article regarding the device tax issue, click here.

ASQ, MWDG holds meeting on biocompatibility and GLP: November 29, 2012, Indianapolis

The MWDG of the ASQ Biomedical Division is next meeting to discuss the topic of biocompatibility in regards to medical devices.

When: November 29, 2012 from 5:30-8:00pm

Where: University of Indianapolis, Schwitzer Student Center Building #7, Room 013, Indianapolis IN 46227

Cost: Buffet dinner, $12.50 for members and $15.00 for nonmembers

Click here to register for the upcoming event. This link will be available until 5pm on Monday, November 26th. If you are unable to use the link, contact Ann Stankiewicz at ann.stankiewicz@roche.com

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 England Journal of Medicine shows that, in fact, FDA has a faster review time than it’s comparatives by over three months. According to the article cited above, the study also indicated that “most new drug therapies were first approved for use in the United States.” Do these new findings suggest that FDA needs to amp up their drug approval process, or that Europe and Canada need to take note of FDA’s method?

Read more on how FDA approves drugs here.