FDA

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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FDA issues rule on safety reporting

Tuesday, October 5, 2010 08:51 AM

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. “These changes will better protect people who are enrolled in clinical trials,” said Rachel Behrman, M.D., associate director for medical policy in the FDA’s Center for Drug Evaluation and Research. The new rule requires certain safety information be reported to FDA within 15 days of becoming aware of an occurrence, including: findings from clinical or epidemiological studies that suggest a significant risk to study participants; serious suspected adverse reactions occurring at a rate higher than expected; serious adverse events from bioavailability studies that determine what percentage and at what rate a drug is absorbed by the bloodstream, and bioequivalence studies that determine whether a generic drug has the same bioavailability as the brand name drug. The rule also provides examples of evidence suggesting an investigational product may be the cause of a safety problem. Currently, sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event. This complicates and delays the FDA’s ability to detect a safety signal. The examples address when a single event should be reported and when to wait for more than one occurrence.

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Chicago HIV researcher ‘vindicated’ by FDA in clinical trial fraud case

Tuesday, September 21, 2010 07:27 AM

Daniel Berger is a happy man. The FDA has ruled that the Chicago internist and thought leader in the area of HIV can continue conducting clinical trials without any restrictions, despite evidence that his clinic submitted bogus data along with failing to perform basic tests including physical exams and electrocardiograms during one particular trial. Additionally, 200 tablets of the investigational drug went missing at his clinic during that trial.

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CenterWatch Monthly August 2010

Wednesday, August 4, 2010 09:18 AM

Spike in Warning Letters Sends Tremors Through Industry

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PPD, Microsoft help manage REMS programs

Wednesday, August 4, 2010 08:07 AM

PPD and Microsoft have entered into an agreement to jointly implement a technology solution designed to improve efficiency in managing U.S. Food and Drug Administration-mandated Risk Evaluation and Mitigation Strategy (REMS) programs.

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UBC to Continue Growth Strategy with New $150 Million in Funding

Monday, July 19, 2010 09:00 AM

Pharmaceutical services company United BioSource Corporation (UBC) will use its newly-secured $150 million line of credit to fuel its fast-paced growth and acquisition spree, CEO Ethan Leder said in an interview with CWWeekly.

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