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Adverse Event Reports Go Digital Only

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FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions.

“This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information with the public,” said Gerald Dal Pan, director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA.

Currently, FDA accepts reports in both paper and digital formats. Since 2000, CDER has allowed drug companies to submit forms electronically via a pilot program. Electronic reports are entered into a database almost immediately if logged through the FDA’s Web gateway, and take a bit longer if submitted on a CD or DVD.

“The proposed rule does not propose any changes to the requirement for what information must be reported to FDA,” Del Pan said in a press conference. “It proposes that the information be submitted electronically rather than on paper.”

Today, FDA laid out two options for electronic submissions. Manufacturers can submit via international electronic standards or through a Web based safety-reporting portal currently under development. According to Del Pan, the Web-based portal is intended for companies with small numbers of reports and for consumers to report side effects directly.

FDA said that the new regulations will improve the overall efficiency of the adverse event reporting process, and that it will cost less to input forms that come in digitally. However, the agency would not disclose the cost of upgrading to the new electronic system.

“A lot of companies are doing this already,” Del Pan said. “We currently receive between 400,000 and 500,000 reports a year, and about 80 percent of those are already coming in electronically, based on the pilot program started in 2000.”

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One Comment

  1. Posted August 28, 2009 at 5:00 pm | Permalink

    Even with 80% of these reports already being submitted in electronic format, let’s hope that the resources saved can be redistributed to other areas where the FDA needs improvement.

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