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There is no sign of a slowdown in letters to the FDA seeking assurances that the agency will not bend to political pressure to approve a COVID-19 vaccine ahead of the Nov. 3 presidential election. Read More
Philip Krause, deputy director of the FDA’s Office of Vaccines Research and Review, said this week that the fate of the agency’s guidance on its expectations for COVID-19 vaccine Emergency Use Authorization (EUA) remains uncertain as it goes through the White House’s review. Read More
The FDA has issued two guidances to help generic drug applicants through the abbreviated new drug application (ANDA) process, including a final guidance on the preferred timing and content for changes to tentatively approved applications. Read More
Australia plans to make more in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza beginning Oct. 1, although self-tests for cancer and genetic testing will not be allowed to be sold to consumers, the Therapeutic Goods Administration (TGA) said. Read More
Operation Warp Speed, the Trump administration’s COVID-19 vaccine and treatment initiative, is in “full alignment” with the FDA raising the bar on what’s required for an Emergency Use Authorization of a COVID-19 vaccine, the top adviser to the initiative says. That contradicts what President Trump has been saying. Read More
Gilead Sciences has agreed to pay $97 million to settle Department of Justice (DOJ) claims that it illegally channeled Medicare copays for its pulmonary arterial hypertension (PAH) drug Letairis (ambrisentan) through a charitable foundation. Read More
In a letter to Eli Lilly this week, HHS General Counsel Robert Charrow rebuked the company over its plans to cut discounts offered through the federal government’s 340B Drug Pricing Program. Read More
The head of the FDA’s vaccine advisory committee has recused herself from its upcoming COVID-19 vaccine review to avoid any appearance of a conflict of interest stemming from her leadership role in Moderna’s vaccine trial. Read More
In a letter sent yesterday, leaders of the House Energy and Commerce Committee demanded that the HHS Office of Inspector General (OIG) conduct a full investigation into politically motivated interference by the White House in the affairs of the Centers for Disease Control and Prevention (CDC) during the pandemic. Read More
New York Gov. Andrew Cuomo is threatening not to distribute FDA-approved COVID-19 vaccines in his state until they receive approval from a state task force of scientists, doctors and health experts. Read More
“This settlement demonstrates the government’s commitment to hold accountable companies that pay illegal kickbacks, whether directly or through a third party,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the DOJ’s Civil Division. Read More
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Thursday that White House interference with the FDA’s policies for authorizing a COVID-19 vaccine would be “troublesome.” Read More