FDA Policy/General

Draft Guide on Safety Data Collection

FDA has released a draft guidance entitled “E19 Optimization of Safety Data Collection.” The document is intended to provide internationally harmonized guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented. “By collecting selective safety data, the burden to patients would be reduced, a larger number of informative clinical studies could be carried out with greater efficiency, studies could be conducted with greater global participation, and the public health would be better served,” the guidance says.

Prior to initiating such a study program, the guidance says sponsors need to provide the scientific rationale for selective safety data collection. Factors to consider in determining when such data collection would be appropriate include the following:

The medicinal product has received marketing authorization from a regulatory authority for the indication under investigation
The dose, dosing regimen, dosage form, route of administration and treatment duration used in the previously conducted studies are comparable to the planned use of the drug in the proposed study
The patient population from previously conducted studies are representative of subjects in the planned study with regard to demographic characteristics, underlying medical conditions, concomitant drugs, and other important factors (e.g., CYP metabolizer status)
Sample sizes of previous studies
Consistency of safety profile across previous studies
Knowledge of the safety profile of the chemical drug class

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome