Hypertension Drug Development To Be Streamlined Under US FDA Guidance
Sponsors will need fewer dosage comparisons in factorial studies of fixed-dose hypertension combination products under the draft guidance.
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Significant effects are expected to be observed on both systolic and diastolic blood pressures, US FDA final guidance says in lone substantive change from January draft aimed at streamlining development for multi-drug combinations of previously approved products; with only five such products in the clinical pipeline according to Biomedtracker data, there appears to be little big pharma interest in this space.
Alzheimer's disease, amyotrophic lateral sclerosis, migraine, and opioid dependence are among conditions that will get drug development guides from FDA; other guidances will address ANDA bioequivalence studies, shared REMS, and continuous manufacturing.
US FDA Commissioner notes that combined-phase clinical trials could be expanded beyond oncology as one way of reducing drug development costs.