Regulatory News In Brief
This article was originally published in The Tan Sheet
Executive Summary
House GOP members raise issues with NDI draft guidance; researchers doubt OTC access for anthrax MedKit; Kux becomes FDA assistant policy commissioner; NAD reviews Vitanergy claims for urinary health supplement.
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Reps Threaten Legislation To Align NDI Guidance With DSHEA
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the House members contacted FDA following the agency’s “dismissal” of a Senate request to withdraw or revise the NDI draft guidance.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.
OTC Anthrax MedKit Development Relies On Incremental Approach
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.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.