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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Decentralized Clinical Trials Among Topics Slated For CDER Guidance In 2020
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.
Clinical Trial Reform Is A Focus For CDER's 2019 Guidance Agenda
US FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.
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will need fewer dosage comparisons in factorial studies of fixed-dose hypertension combination products under the draft guidance.