title: Roles and contributions of pharmacists in regulatory affairs at the Centers for Disease Control and Prevention for public health emergency preparedness and response.
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.
  
  
  METHODS
  Atlanta, GA.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: National Center for Emerging and Zoonotic Infectious Diseases (proposed), Centers for Disease Control and Prevention, Atlanta, GA, USA. asn2@cdc.gov
authors.forename: Tina R
authors.initials: TR
authors.lastname: Bhavsar
authors.forename: Hye-Joo
authors.initials: HJ
authors.lastname: Kim
authors.forename: Yon
authors.initials: Y
authors.lastname: Yu
mesh_terms: D002487:Centers for Disease Control and Prevention, U.S.; D002959:Civil Defense / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D004196:Disease Outbreaks / Q000517:prevention & control; D004632:Emergency Medical Services / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D033161:Government Regulation; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control / Q000821:virology; D010595:Pharmacists; D024382:Professional Role; D014481:United States; D000078329:Workforce