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Latest From Sarah Karlin-Smith
The Trump administration says a COVID-19 vaccine could be available in as little as 12 months, but most experts think that is overpromising unless safety or efficacy standards are sacrificed. Many are urging pivotal studies that look at clinical outcomes, not surrogates, for US FDA approval.
Eschewing the standard approval mechanisms for COVID-19 vaccines is likely only appropriate in very limited high-risk populations, unless clinical efficacy outcomes are available, former FDA leaders say.
FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments
Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs.
What's in – and what fell out of – the massive US stimulus package.
Early versions of US Congress's coronavirus relief bill contained a number of policies that would have benefited drug firms, but they didn't make it into the final bill. However, the $2 trillion package does provide pharmaceutical companies with relief from the threat of drug pricing reform until after the 2020 elections.
Senate and House versions of a pending coronavirus stimulus package take off the table a key legislative vehicle lawmakers planned to use to push for bipartisan drug pricing reform until at least after the 2020 elections, signaling a potential reprieve for the pharmaceutical industry.