Latest from Sarah Karlin-Smith
Pink Sheet interviews with ex-FDA leaders and agency experts offer guidance for drug developers navigating an agency playing by a different and ever-shifting rulebook.
Administrative Procedure Act challenges are expected after sweeping changes to the US vaccine schedule were made that experts said were not based on sound science.
The US Centers for Medicare and Medicaid Services argued gender affirming care is not health care to help justify the new proposed rules. The argument could create a new opening for the federal government to go after other pharmaceuticals.
Martin Makary’s photo-op and videos promoting the groundbreaking of a new Novartis US-based manufacturing facility create an appearance of favoritism, President George W. Bush’s former chief ethics lawyer told the Pink Sheet.
As differences emerged between FDA staff and senior political leaders over its COVID-19 safety review, CBER Director Vinay Prasad added an old colleague and critic of US COVID-19 policy to the center.
At an expert panel overwhelmingly composed of people favoring expanded testosterone use and loosened safety warnings, career FDA staff suggested new clinical trials would be required to approve some of the changes.
