Drugs

Comments on Patient-Focused Development Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts to advance patient-focused drug development through a guidance and public workshop. The association says it agrees with FDA on the importance of sponsors engaging with the agency early to discuss clinical outcome assessment development strategy. It recommends that the guidance clearly state that sponsors should begin such discussions early in development and engage early with the agency as this could help improve efficiency and help save time in a sponsor’s development program.

PhRMA recommends that FDA cross-reference all of the four guidances in the patient-focused drug development series in all four to ensure that all patient-focused drug development principles are applied in clinical outcome assessment development and implementation.

Roche/Genentech commented on the need for consistent terminology, clarity regarding the review of patient experience data, and innovation and collaboration to address measurement challenges.

Specific line-by-line comments were submitted by these two stakeholders plus Otsuka and Critical Path Institute.

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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