Drugs

Comments on Surrogate Endpoint Table

Pharmaceutical Research and Manufacturers of American (PhRMA) says FDA should consider publicly disclosing supporting documentation and information for surrogate endpoints used for approvals of NDAs and BLAs with all necessary protections for trade secrets and confidential information, as is the practice with qualified biomarkers, and should use the List of Qualified Biomarkers as the template and standard for which information should be included in the surrogate endpoint table. The recommendation is in the association’s comment letter on the agency’s draft guidance on establishment of a surrogate endpoint table as required under the 21^st Century Cures Act.

PhRMA says the current version of the table does not address the amount of data supplied in each case to enable use of a surrogate endpoint for approval of an NDA or BLA. “Providing the FDA review information … in the surrogate endpoint table would provide sponsors the clarity around the amount and type of data FDA has considered sufficient, as well as clarity around the patient population associated with each endpoint,” the letter says.

The Critical Path Institute comments that development of a table of surrogate endpoints “is a single, but meaningful step toward information sharing that can contribute to more efficient medical product development and innovation.”

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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