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 In this section:

                Safety & Availability (Biologics)

Safety & Availability (Biologics)

                        Biologic Product Security
          Blood Safety & Availability
          CBER-Regulated Products: Shortages and Discontinuations
          Pandemics & Emerging Diseases
          Tissue Safety & Availability
          Vaccine Safety & Availability


                        HIV Home Test Kits
          Recalls (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research Home
          Vaccines, Blood & Biologics
          Safety & Availability (Biologics)
          Countering Bioterrorism and Emerging Infectious DiseasesSafety & Availability (Biologics) Countering Bioterrorism and Emerging Infectious Diseases
  
  	
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    Print**Facilitating the Development of Medical Countermeasures**

The U.S. Government’s efforts to counter bioterrorism are comprised of a number of essential elements for which CBER plays an integral role. One such element is the expeditious development and licensing of products to diagnose, treat or prevent disease following exposure to pathogens that have been identified as bioterrorist agents. These products must be reviewed and approved prior to the large-scale productions necessary to create and maintain a stockpile. Staff must guide the products through the regulatory process, including the manufacturing process, pre-clinical testing, clinical trials, and the licensing and approval process. Experts in these areas are needed to expedite the licensing and approval process for these products. This process is extremely complex and early involvement by staff is crucial to the success of the expedited review process.

CBER works with other federal agencies and industry, through the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) on a broad array of projects aimed at making our nation better prepared for chemical, biological, radiological, and nuclear (CBRN) threats and emerging infectious diseases through the development of new countermeasures.

In addition, CBER also monitors the impact of emergencies or outbreaks of disease on the safety and availability of the blood supply.

Preparedness for and response to an attack involving biological agents are complicated by the large number of potential agents (most of which are rarely encountered naturally), their sometimes long incubation periods and consequent delayed onset of disease, and their potential for secondary transmission. In addition to naturally occurring pathogens, agents used by bioterrorists may be genetically engineered to resist current therapies and evade vaccine-induced immunity. Pathogens that have been identified as potential biological warfare agents include those that cause anthrax, botulism, plague, smallpox, tularemia, and the hemorrhagic fevers, among others.

David Cho, PhD, Senior Advisor for Preparedness and Response
	David A. Rouse, M.S., Senior Scientist for Counterterrorism and Emerging Threats Preparedness
	Nicolette C. deVore, Ph.D., Senior Scientist and Project Manager for Counterterrorism and Emerging Threats PreparednessRelated Information

Countering Bioterrorism Questions and Answers
	Anthrax
	Smallpox
	Guidance: Emergency Use Authorization of Medical Products
	Medical Countermeasures Initiative (MCMi)
	Vaccine Safety and Availability
	Questions about Vaccines
	Blood & Blood Products
	Science and Research
	Highlights of CBER's Medical Countermeasure Regulatory Science and Research Program - ARCHIVED
	Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)

                                                                                  Content current as of:
      09/21/2020Safety & Availability (Biologics)

          
                        Biologic Product Security
          Blood Safety & Availability
          CBER-Regulated Products: Shortages and Discontinuations
          Pandemics & Emerging Diseases
          Tissue Safety & Availability
          Vaccine Safety & Availability


                        HIV Home Test Kits
          Recalls (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research
 
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