Regulatory Roundup: FDA Issues Guidance on In Vitro Diagnostic 2009 H1N1 Tests, More....

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system.

The US Food and Drug Administration published on Nov. 2, 2009, a guidance for industry and staff on In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to FDA for an Emergency Use Authorization (EUA), according to an agency release about the guidance. This guidance outlines what information manufacturers need to include in EUA requests. The EUA authority allows FDA to authorize use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a declaration of emergency, when certain criteria are met. Department of Health and Human Services Secretary Kathleen Sebelius declared such an emergency period for H1N1 in April 2009.

In related news, Novartis (Basel, Switzerland) confirmed last week that it has shipped more than 7.5 million doses of Influenza A (H1N1) vaccine and expects 25 to 30 million doses of unadjuvanted vaccine to become available in prefilled syringes and multidose vials by the end of November. “Production of the H1N1 vaccine is progressing, despite the unexpected very low yields observed with the initial seed virus at 23% as compared to average yield seen with seasonal vaccines,” said the company in a release.

FDA and WebMD Health Corporation have expanded their partnership, according to late October news releases. The partnership, started in December 2008, aims to provide viewers with access to the agency’s consumer health information. WebMD will now include additional content and multimedia tools based on FDA information.


FDA awarded contract research organization PPD a $2.7-million contract to evaluate the agency's Center for Drug Evaluation and Research (CDER) postmarket spontaneous-adverse-event surveillance system. PPD will conduct a thorough evaluation of the value of the system and report its findings, according to a PPD release. The two-year project falls under FDA's Initiative for Maximizing the Benefit of Passive Adverse Event Collection throughout a Product's Life Cycle (IMPACT), which is aimed at fulfilling a Prescription Drug User Fee Act (PDUFA) IV commitment. FDA will use PPD’s findings to develop an implementation strategy for ensuring optimal use of the system, according to the release.