Drugs

Suggestions for ICH Good Clinical Practice Guideline

Pharmaceutical Research and Manufacturers of America (PhRMA) says it applauds efforts by the International Council for Harmonization (ICH) and FDA to facilitate harmonized scientific and regulatory considerations for Good Clinical Practice (GCP). Responding to FDA’s publication of the ICH E6(R3) draft guideline, PhRMA says it supports the revision of the ICH document and FDA’s efforts to help facilitate more effective risk-based strategies for designing, conducting, and reporting of trials involving human subjects, and to help ensure the safety and well-being of trial subjects. While generally supporting the revision, PhRMA submits some recommended revisions for clarity.

In its response, the American Association of Pharmaceutical Scientists makes these points:

there are generalized statements throughout the document that are vague and may add confusion to the intended audience;
when considering patients’ well-being at the end of their participation in a clinical trial, statements should be added for patients with a disease requiring the investigator, physician, or sponsor (sic);
roles assigned in the document to the sponsor and investigator are sometimes not clear or are limited to one or the other, when in the practical operation of clinical trials they reside with both;
when the document considers good decision-making, there are no specifics as to who is making the decision based on the information gathered and generated within a clinical trial; and
there are sections of the guidelines related to GMP practices and the quality of the investigational product that are vague and should reference the ICH quality guidelines.

The Association of Clinical Research Professionals and the Association for Accessible Medicines submitted charts with line-by-line technical 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