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House GOP members raise issues with NDI draft guidance; researchers doubt OTC access for anthrax MedKit; Kux becomes FDA assistant policy commissioner; NAD reviews Vitanergy claims for urinary health supplement.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the House members contacted FDA following the agency’s “dismissal” of a Senate request to withdraw or revise the NDI draft guidance.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.
The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab.