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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. 25 mg)” — such doses had been suggested in the Citizen Petition.

Science 40
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Re-assessing the risks of drug-induced arrhythmias during drug discovery

Drug Discovery World

Cardiovascular diseases are the leading cause of death globally. A more recent analysis has illustrated how both assay validity and reproducibility correlate across a population of simulated screening and disease models 2. Unexpected late-stage failures in drug development are, of course, the costliest.

Drugs 130