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Attorneys for two Ohio counties said the overdose deaths, overwhelmed courts, social services agencies and law enforcement cost each of the counties approximately $1 billion. Read More
The FDA has issued recommendations for sponsors who are hoping to use real-world data from registries to support regulatory approval of a new drug or biologic. Read More
In a pair of tweets, U.S. Trade Representative Katherine Tai said the U.S. would persist in pressing for members of the World Trade Organization (WTO) to move ahead with an intellectual property framework for COVID-19 vaccines. This, after an important in-person WTO ministerial meeting this week was postponed due to the fast-spreading Omicron variant. Read More
The European Union appears to have reversed its previous stance on intellectual property (IP) waivers for COVID-19 vaccines and therapeutics. Instead of threatening to veto IP waivers in ongoing World Trade Organization (WTO) negotiations, it is now backing them. Read More
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