FDA

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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FDA Inspecting Few Overseas Sites

Thursday, July 8, 2010 07:57 AM

More than three quarters of all clinical trial subjects were enrolled overseas, and yet the FDA inspected just 45 foreign investigative sites in 2008. That’s just 0.7% of all overseas sites that enrolled a trial subject.

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SAFE-BioPharma Signing up Sites, CROs

Wednesday, June 23, 2010 08:48 AM

Contract research organizations (CROs) and investigative sites have begun to adopt SAFE-BioPharma digital identities, which are already widely used by biopharmaceutical companies, in order to sign contracts and other clinical trial documents electronically.

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Parexel Hires Former FDA, MHRA Regulators

Tuesday, June 22, 2010 10:01 AM

Parexel Consulting, a business unit of Parexel International, has appointed former regulators Toby Silverman, M.D. and Keith Watson, Ph.D. as principal consultants.

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Pfizer Warned by FDA for Inadequate Monitoring in Peds Study

Friday, April 23, 2010 07:01 AM

Pfizer received a warning letter from the U.S. Food and Drug Administration (FDA) last week, citing the pharmaceutical giant for inadequate clinical trial monitoring in the study of a pediatric drug—violations that led to the overdosing of at least 26 children.

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Clinical Trial Activity in Russia Dipped in 2009

Friday, March 5, 2010 06:56 AM

According to Russia-based contract research organization (CRO) Synergy Research Group’s Annual Orange Report, Russia’s regulatory agency Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (RosZdravNadzor, RZN) approved 577 new clinical trials during 2009, 6% fewer than in 2008. Sixty percent, or 348 of the new studies, were multinational multi-center trials, down 4% from 2008.

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