FDA

Technology companies adapt interactive video concepts for clinical trial informed consent

Monday, February 14, 2011 10:15 AM

Interactive videos, complete with soothing voices, explain hospital surgeries step-by-step, along with the risks and benefits, to enable patients to make informed decisions. Now, producers of these videos are adapting them for the clinical trials space, which for decades has relied on paper documents that often fail to adequately inform prospective volunteers.

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The CenterWatch Monthly February 2011

Thursday, February 3, 2011 01:08 PM

The High Cost and Questionable Impact of 100% SDV 

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FDA issues 19 action items to improve transparency

Tuesday, January 18, 2011 12:22 PM

As part of its ongoing transparency initiative, the U.S. Food and Drug Administration has issued 19 action items including a new website to help the industry save time and resources in its interaction with the agency.

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Maryland woos away top deputy at the FDA

Wednesday, January 5, 2011 12:21 PM

Joshua M. Sharfstein, the second-in-command at the Food and Drug Administration, is leaving that post after less than two years to become Maryland's top public health official, Gov. Martin O'Malley said Tuesday and as reported by The Washington Post.

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Survey: relationship between FDA and life sciences industry deteriorating, delays in review process cited

Monday, December 13, 2010 07:00 AM

Top biopharmaceutical company executives are frustrated with delays and inconsistencies in the Food and Drug Administration (FDA) regulatory review process and are concerned that passage of the healthcare reform law, which gave the already resource-constrained agency more responsibilities, will further complicate drug approvals, according to a new PricewaterhouseCoopers (PwC) survey.

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It’s holiday bonus time—or is it? Investigative sites split on ethics of bonuses

Friday, December 10, 2010 01:44 PM

For many workers, December is not just the holiday season. It’s the season of the holiday bonus.

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FDA: Generic transdermal patches should be tested in divergent climates

Monday, November 22, 2010 09:06 AM

A patch that delivers medicine transdermally may act very differently on a resident of Fargo, N.D., than on someone in South Florida. Thus, the amount of medicine that enters their bloodstreams may be different. That’s the assertion of the FDA’s Office of Generic Drugs, and that’s why the regulatory body now asks that drug developers working on transdermal patches—at least in the generics realm—test their patches in multiple divergent climates.

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Site Solutions survey: Lack of operating capital, cash flow plague investigative sites

Monday, November 15, 2010 09:17 AM

Sixty percent of investigative sites have less than three months of operating cash on hand in the bank, according to the 2010 Site Solutions Summit survey.

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Grants awarded to research benefits of adaptive clinical trial design, identify barriers

Monday, November 8, 2010 11:16 AM

Researchers at the University of Michigan have received a $1.5 million grant to demonstrate how adaptive clinical trial design can improve the speed, efficiency and safety of clinical research. As part of the three-year project, the researchers also will identify barriers to widespread adoption of these innovative trial designs in academic research.

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ProPublica report: big pharma paid hundreds of physicians over $100,000 in speaking fees

Monday, November 8, 2010 11:12 AM

Several doctors paid to speak on behalf of big pharmaceutical companies aren’t, in fact, the thought leaders consumers often consider them to be, but instead have been sanctioned for various forms of misconduct. And psychiatrists collect more in speaking and consulting fees from pharma companies than doctors in any other specialty.

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