Disease-Specific Drug Development Guidances Coming From US FDA In 2018
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.
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US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.
US FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.
Sponsors will need fewer dosage comparisons in factorial studies of fixed-dose hypertension combination products under the draft guidance.