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Special Feature
Roles and contributions of pharmacists in regulatory affairs at the Centers for Disease Control and Prevention for public health emergency preparedness and response
Tina R. Bhavsar, PharmD; Hye-Joo Kim, PharmD; Yon Yu, PharmD
J Am Pharm Assoc (2003) 2010;50:165-168. doi:10.1331/JAPhA.2010.09220

Abstract

Objective  To provide a general description of the roles and contributions of three pharmacists from the Regulatory Affairs program (RA) at the Centers for Disease Control and Prevention (CDC) who are involved in emergency preparedness and response activities, including the 2009 pandemic influenza A (H1N1) public health emergency.

Setting  Atlanta, GA.

Practice description  RA consists of a staff of nine members, three of whom are pharmacists. The mission of RA is to support CDC's preparedness and emergency response activities and to ensure regulatory compliance for critical medical countermeasures against potential threats from natural, chemical, biological, radiological, or nuclear events.

Conclusion  RA was well involved in the response to the H1N1 outbreak through numerous activities, such as submitting multiple Emergency Use Authorization (EUA) requests to the Food and Drug Administration, including those for medical countermeasures to be deployed from the Strategic National Stockpile, and developing the CDC EUA website (www.cdc.gov/h1n1flu/eua). RA will continue to support current and future preparedness and emergency response activities by ensuring that the appropriate regulatory mechanisms are in place for the deployment of critical medical countermeasures from the Strategic National Stockpile against threats to public health.

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References

Patel A, Gorman SE. Stockpiling antiviral drugs for the next influenza pandemic Clin Pharmacol Ther. 2009;86:241–3.[PubMed][CrossRef]
 
Parker RM, Wolf MS, Jacobson KL, Wood AJ. Risk of confusion in dosing tamiflu oral suspension in children N Engl J Med. 2009;361:1912–3.[PubMed]
 
 Centers for Disease Control and Prevention. Update: Influenza activity–United States, April-August 2009 MMWR Morb Mortal Wkly Rep. 2009;18;58:1009–12.
 
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