Experts: Molecular Tests Could Improve Antibiotic Clinical Trials
This article was originally published in The Gray Sheet
Executive Summary
Greater acceptance of molecular tests that can identify rare and drug-resistant bacterial strains through their genetic material could transform antibiotics clinical trial design and lower the cost of developing new drugs, scientists said at a workshop on antibiotic drug resistance last week
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New Diagnostics Address Foodborne Illness Outbreaks
FDA is showcasing new diagnostic technologies to address foodborne illness outbreaks, including a new test kit from a German manufacturer and a next-generation sequencing method developed by agency scientists.
New Diagnostics Address Foodborne Illness Outbreaks
FDA is showcasing new diagnostic technologies to address foodborne illness outbreaks, including a new test kit from a German manufacturer and a next-generation sequencing method developed by agency scientists.
Regulatory News In Brief
Conflict of interest comments: The American Association for Justice urges stricter requirements for advisory committee members with financial conflicts in June 21 comments on FDA's latest draft guidance regarding advisory committee member financial conflicts of interest and waivers. AAJ, formerly the Association of Trial Lawyers of America, believes conflicted persons should not be allowed to serve even as non-voting members, because "a non-voting member can still wield enough influence ... to upset the vote," the group writes. The Breast Cancer Action group, meanwhile, urges FDA to create guidelines requiring agency staff to contact a specific number of experts before a waiver can be deemed necessary. The March 2010 draft guidance is FDA's third attempt to carve out policies for financial conflicts of interest, following a draft guidance in 2002 and final guidance in 2008 (1"The Gray Sheet" April 26, 2010). The recent draft amends the prior versions to require public disclosure of the source of financial conflicts, which several commenters applauded