FDA Lengthens Comment Period on New Biomarkers

The FDA is giving industry and other interested parties another 30 days to weigh in on its request for suggestions on new biomarkers to speed drug development, according to an FDA notice.

Comments are now due by May 15, the FDA says in the Federal Register.

The FDA in February sought suggestions on new biomarkers that could help define appropriate patient populations in clinical trials and provide pharmacodynamics markers. The original deadline for comments was April 14.

However, that initial 60-day comment period wasn’t enough time for the broad public response the FDA is seeking, the agency says. The extension should allow enough time for additional comment without significantly delaying progress on biomarker development, the FDA adds.

At last check, just two comments had been noted on Regulations.gov, although parties often wait until the last minute to weigh in.

Since 2008, the FDA has qualified four biomarkers: two for drug-induced nephrotoxicity and one each for drug-induced cardiotoxicity and invasive aspergillosis.

View the Federal Register notice at www.fdanews.com/04-02-15-QualificationBiomarkers.pdf. — Bryan Koenig