Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.
US Food and Drug Administration chief scientist Denise Hinton will decide the fate of the preterm birth prevention drug Makena now that the agency has granted sponsor Covis Pharma’s request for a public hearing in its fight to retain accelerated approval.
In an 18 August
US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.
Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.
The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.
Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
