FDA Warning Letter Re: Fatal Experiment: Hexamethonium Inhalation_Johns Hopkins

FDA Warning Letter Re: Fatal Experiment: Hexamethonium Inhalation_Johns Hopkins Tue, 22 Apr 2003 An FDA Warning Letter was sent to Dr. Alkis Togias of the Johns Hopkins University Asthma & Allergy Center (March 31, 2003). The letter lists specific federal safety requirements . . . Continue reading →

Children are Humans: Don’t Sacrifice their Rights, Dignity & Welfare

We are writing about the Pediatric Research Equity Act of 2003 (S 650). We are in full agreement that children should have the same safeguards as adults; that medications used in children be thoroughly tested for safety, effectiveness and appropriate dose. However, S 650 does not do this. Instead, it requires that children be used to test all drugs as a condition of licensure by FDA – unless a waiver is obtained from the Secretary of the department of Health and Human Services under section 505B.

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