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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. For this approach, a “3+3” model is used where a study enrolls three patients into a given dose cohort.

FDA

FDA Side effects Pharmacology Patients

Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

JANUARY 22, 2023

Dr. Jerry Mendell, MD, professor of paediatrics and neurology at the Ohio State University College of Medicine, is optimistic for its approval and says the drug has a good safety profile. However, before the drug can receive an approval, Santhera will have to overcome doubts about vamorolone’s safety. compared to 38.5% on placebo.

FDA

FDA Safety Pharmaceutical Patients

Pharma Rep Focus

FDA drug dosage optimisation guidelines signal clinical trial reform

Can the FDA keep the momentum going for rare disease drug approvals?

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