News Flood of warning letters follows DTC ad clampdown The FDA has lost no time following through on its plan to tighten up DTC advertising of medicines, sending out dozens of untitled and warning letters.
News FDA's Makary explains 'overdue' pharma ads crackdown FDA Commissioner Marty Makary has called DTC ads for medicines a "public health crisis" as the industry prepares for a regulatory crackdown.
News HHS, FDA drop major DTC advertising policy changes HHS and FDA announced a new policy change that would require pharma companies to list drug information much more extensively in broadcast ads.
News FDA lends a hand to Novo, Lilly on illegal GLP-1 imports The FDA has set up a green list of overseas sources for GLP-1 ingredients to try to block imports of illegitimate and potentially unsafe materials.
News FDA releases previously unseen CRLs in transparency push The FDA's earlier decision to publish complete response letters was largely a repackaging of existing information, but now it has gone much further.
News A vaccine adcomm expert criticised RFK Jr – now he's out A prominent critic of RFK Jr's approach to vaccination regulation, Dr Paul Offit, has been removed from an influential FDA advisory committee.
R&D The long-delayed promise of the microbiome, with Sam Possemi... Sam Possemiers, CEO of MRM Health, believes that the microbiome space is finally coming into maturity.
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