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House GOP members raise issues with NDI draft guidance; researchers doubt OTC access for anthrax MedKit; Kux becomes FDA assistant policy commissioner; NAD reviews Vitanergy claims for urinary health supplement.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the House members contacted FDA following the agency’s “dismissal” of a Senate request to withdraw or revise the NDI draft guidance.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.
Much of the biopharma and other health-related industries in China were already feeling the chill from ongoing macro-economic and other headwinds this year, which now look set to be complicated further by the added strain of social unrest over strict COVID containment policies. The combination of factors is already prompting some to take steps towards restructuring and divestments to survive.