Drugs

Changes Sought in FDA Pharmacokinetics Guidance

GlaxoSmithKline says that while it agrees with FDA’s need to have access to additional supportive files in population pharmacokinetics analyses, the current portal for submissions makes the process challenging. Its comment letter says that very few file types are supported and most of the file formats routinely used by pharmacometricians need to be converted to another format prior to submission. “If FDA would make it possible to submit ZIP files as original model run files (which can directly be run by the reviewers), it would greatly reduce the burden on both submitters and reviewers as it would obviate the need to convert and back-convert files,” the company says. “Also, it would allow subfolder structures to be preserved, which would make it easier for reviewers to find the files that they need.”

Merck says that discussion on biologics or other modalities would be beneficial given their importance in the current product development landscape and their unique features. “Specific points of interest include free vs. total concentration data, target mediated drug disposition, [and] impact of immunogenicity for biologics.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) comment letter says the draft “provides a high-level overview of what is expected from sponsors when performing and submitting a population PK analysis to the agency. PhRMA recommends FDA add more specific examples or literature references throughout to provide detail to the high-level recommendations and to support the technical statements in the draft guidance.”

The Pfizer comment letter says the company “supports the agency’s thoughtful approach to population pharmacokinetics analysis to inform drug development and drug use. Our comments are intended to point out where more specific directions would make the guidance clearer and allow more efficient use of this methodology.”

Finally, Bayer expresses appreciation for the very comprehensive draft guidance.

All five submissions included specific and line-by-line comments.

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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