Regulatory News In Brief
This article was originally published in The Tan Sheet
House GOP members raise issues with NDI draft guidance; researchers doubt OTC access for anthrax MedKit; Kux becomes FDA assistant policy commissioner; NAD reviews Vitanergy claims for urinary health supplement.
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The letter from the office of caucus co-chair Rep. Burton says the House members contacted FDA following the agency’s “dismissal” of a Senate request to withdraw or revise the NDI draft guidance. Rep. Ron Paul, a candidate for the GOP nomination for president, also signed the letter.
HHS’ Biomedical Advanced Research and Development Authority will ask FDA and its advisors about the feasibility of an OTC antibiotic MedKit for anthrax treatment at an advisory committee meeting.
EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.