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Posted by John Lehmann on Fri, Jun 03, 2016

38 Million Reasons to Improve Clinical Trials

On Friday, May 23, 2014 the Federal Register announced a notice that in an effort to increase the quality and efficiency of clinical trials, the Food and Drug Administration (FDA) was planning to grant a one-year, $7,500,000 grant to Duke University’s Translational Medicine Institute (DTMI) (renewable up to a total of five years, $37,500,000). This grant would primarily go to fund the public-private partnership Clinical Trials Transformation Initiative (CTTI).  CTTI  was originally created as a partnership between the FDA and Duke University in 2008, but now includes more than 60 organizations with representatives from government agencies, industry, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.

Topics: DTMI, Federal Register, FDA, Clinical Research

Posted by Michael Marotta on Thu, Jul 19, 2018

38 Million Reasons to Improve Clinical Trials

On Friday, May 23, 2014 the Federal Register announced a notice that in an effort to increase the quality and efficiency of clinical trials, the Food and Drug Administration (FDA) was planning to grant a one-year, $7,500,000 grant to Duke University’s Translational Medicine Institute (DTMI) (renewable up to a total of five years, $37,500,000). This grant would primarily go to fund the public-private partnership Clinical Trials Transformation Initiative (CTTI).  CTTI  was originally created as a partnership between the FDA and Duke University in 2008, but now includes more than 60 organizations with representatives from government agencies, industry, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.

Topics: Improve Clinical Trials, Federal Register, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

Does a Lack of Device Labeling Standard put Patients at Risk?

Recently an announcement of a Public Workshop was posted on Federal Register (FR). This workshop, “Accessible Medical Device Labeling in a Standard Content and Format,” is to investigate the growing need for medical devices to be labeled in a clear and concise manner. Currently, there is a lack of direct regulation that defines a standard for medical device labeling. FDA hopes this workshop will begin the process of establishing a standard.

Topics: Patients, Federal Register, Device Labeling, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

How Would You Improve FDA’s Device Review Process?

This is a question that FDA is asking the public. Recently on Federal Register, the FDA announced an opportunity for the public to comment as part of an assessment process of the medical device review/submissions.  This opportunity stems from the MDUFA Commitment Letter, where FDA has a section describing the assessment of review process management to meet certain performance goals agreed to by industry and FDA.

Topics: Device Review Process, Federal Register, FDA, 510(k)

Posted by Sandra Maddock on Wed, Mar 04, 2015

New FDA Draft Guidance: Electronic Source Data

As technology evolves, it is only natural that there will new ways to consider doing the same task. FDA is catching this wave of the future with the new FDA Draft guidance titled, “Electronic Source Data in Clinical Investigations.” As this draft guidance promotes the electronic age we’re evolving into, FDA hopes this will assist source data overall in clinical research.

Topics: Electronic Source Data, FDA Draft Guidance, Federal Register

Posted by Brandy Chittester on Wed, Mar 04, 2015

5 Questions FDA Asks Regarding UDI Rule

Currently, the FDA is in the process of developing an implementation strategy and policy for the proposed Unique Device Identification (UDI) Rule. While this has been in the works for quite some time, still more changes are being made and more questions are being raised concerning this rule.

Topics: UDI Rule, FD&C Act, Federal Register, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

FDA: Is a Better Postmarketing Surveillance System Needed?

Resulting from performance concerns of many devices, questions have surfaced on whether the current postmarket surveillance system is “optimally structured to meet the challenges of rapidly evolving medical devices and the changing nature of health care delivery and information technology.” This was noted in a recent release in the Federal Register which also announced the public meeting being held by FDA to examine the issue of postmarket surveillance.

Topics: Postmarketing Surveillance System, Federal Register, FDA

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