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Volume 5, Number 4—August 1999


Vaccines, Pharmaceutical Products, and Bioterrorism: Challenges for the U.S. Food and Drug Administration

Kathryn C. Zoon
Author affiliation: U.S. Food and Drug Administration, Rockville, Maryland, USA

Main Article


Proposed activities of the U.S. Food and Drug Administration to counter bioterrorism

1. Enhancing the expeditious development and
licensure of new vaccines and biological
therapeutics through research and review
activities—anthrax vaccine and antisera to
botulinum toxin, for example.
2. Enhancing the timeliness of application reviews of
new drugs and biological products and new uses of existing products.
3. Participating in the planning and coordination of public health and medical response to a terrorist attack involving a biological or chemical agent(s).
4. Participating in the development of rapid detection and decontamination for agents of bioterrorism such as Clostridium botulinum toxins, Yersinisa pestis, Bacillus anthracis.
5. Ensuring the safety of regulated foods, drugs, medical devices, and biological products; arrange for seizure and disposal of affected products.
6. Developing techniques for detection of genetic modifications of microorganisms to make them more toxic or antibiotic-or vaccine-resistant.
7. Rapidly determining a microbe's sensitivity to drug therapy.
8. Determining the mechanism of replication and pathogenicity or virulence of identified organisms including elements that can be transferred to other organisms to circumvent detection, prevention, or treatment
9. Enhancing adverse product reporting surveillance capabilities.

Main Article

Medline indexes "Am J Public Health" but cannot find a listing for the reference 2 "Brachman, Gold, Plotkin, Fekety, Werrin, Ingraham, 1962". Please check the reference for accuracy.