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Due to the Biden Administration’s failure to furnish Congress with papers by the deadline, Robert Califf is unlikely to get a full Senate floor vote on his nomination for the role of Commissioner of the FDA before the end of 2021. Read More
Did former FDA Commissioner Stephen Hahn cave to political pressure from the Trump Administration in authorizing hydroxychloroquine and convalescent plasma as treatments for COVID-19 even though there was scant evidence of their efficacy? Read More
The UK’s National Institute for Clinical Evidence (NICE) has given a thumbs-up to the first dual-agent injectable HIV-1 treatment for use by the National Health Service (NHS). Read More
The FDA has closed out its three-year-old warning letter to Zhejiang Huahai Pharmaceutical’s site in Linhai, Taizhou because of corrective actions the manufacturer has undertaken. Read More
There aren’t enough drugs under development to treat antibacterial and antifungal infections in patients with limited treatment options, even though the FDA offers a particular pathway to help expedite such candidates, the Government Accountability Office (GAO) has reported. Read More
After a long night which saw a vote on the Build Back Better Act delayed for many hours, the House of Representatives on Friday morning finally passed the nearly $2 trillion Build Back Better Act — including provisions meant to reduce the price of some prescription drugs. Read More
“The FDA can and should harness its enforcement tools to ensure timely submission of trial results information to ClinicalTrials.gov,” wrote the researchers. Read More