Market Access Working in the grey: FDA, CMS and data privacy For companies in the biotech space, it’s never been easy to navigate the legal and business risks inherent in a highly regulated, dynamic industry – and it’s only becoming more complicated
Market Access New FDA head says no more pharma on advisory committees The announcement signals a new administration attempting to distance itself from industry, but the actual impact seems small.
News FDA plans to phase out animal testing for antibodies The FDA has said it intends to reduce or replace animal testing of some medicines, including monoclonal antibodies, with other methods.
News RIF job losses are underway at HHS agencies; reports Reduction in force (RIF) job losses have started in earnest at US federal agencies, including the FDA and CDC, according to media reports.
News Industry alarm as FDA's CBER head Peter Marks resigns Industry organisations are alarmed by the resignation of senior FDA official Peter Marks, citing "misinformation and lies" by HHS Secretary Kennedy.
News HHS plans 10,000 more job cuts, taking target to 20,000 HHS Secretary Kennedy has said he intends to save $1.8bn per year, thanks to another wave of job cuts affecting the FDA, CDC, NIH, and CMS.
News FDA finally okays Novavax's COVID-19 jab, with restrictions The FDA has granted full approval to Novavax's COVID-19 vaccine after a delay, but has limited its use.
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