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Anthrax MedKit Initiative Could Learn From OTC Studies – NDAC

 
• By Dan Schiff

FDA’s Nonprescription Drugs Advisory Committee recommends the HHS sponsors of an antibiotic MedKit take lessons from OTC drug development. But many advisory panel members at an April 2 meeting did not see clear benefits of allowing home stockpiling of doxycycline to treat anthrax.

The Department of Health and Human Services agency developing an antibiotic home-use MedKit as an anthrax attack countermeasure should look to the OTC drug development process for guidance, including the design of actual use studies, FDA advisors say.

However, several experts at an April 2 joint meeting of the Nonprescription Drugs and Anti-Infective advisory committees in Silver Spring, Md., said they did not see clear benefits of allowing...

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