Ethics/Regulatory

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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Sponsors must consider the challenges as well as advantages when moving trials to emerging markets

Monday, January 10, 2011 07:00 AM

As drug sponsors increasingly look to emerging markets for greater patient access and lower trial costs, they must also consider the potential disadvantages of moving operations to a developing country when choosing the best location for a clinical trial, according to new research from Cutting Edge Information.

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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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The CenterWatch Monthly December 2010

Monday, November 29, 2010 12:30 PM

Pessimism and instability defining the clinical research workforce

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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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U.S. Chamber of Commerce mission to India focuses on collaboration, innovation in growing biosimilars market

Monday, November 15, 2010 09:10 AM

As drug development grows ever more global, India continues to stand out as one of the key places to be. And with President Barack Obama having just wrapped up a high-profile, economic-focused trip to India last week, it’s clear that doing business with and in this country is a top priority across many sectors.

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Goodwyn IRB launches “site university” to apply good clinical practices to real-life situations

Tuesday, October 19, 2010 07:50 AM

In the 11 years since she founded Cincinnati-based Goodwyn IRB, Ellen Kelso says she’s noticed a great deal of non-compliance among investigators on the trials she’s overseen. Those making the mistakes had good clinical practices (GCP) training, but they somehow weren’t able to apply it to real-life situations in the course of a trial, she said.

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NIH official sees need to evaluate effectiveness of IRBs in protecting study volunteers

Monday, October 18, 2010 07:40 AM

Institutional Review Boards (IRBs) are central to the system of protecting human subjects who participate in clinical research, yet concerns have been raised that there is no way to measure whether IRBs actually do their job of protecting study volunteers from unnecessary risk of harm.

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