• Regulatory NewsRegulatory News

    Biden administration outlines plan to address US supply chain vulnerabilities

    The United States is taking steps to address vulnerabilities in US supply chains, according to a new report published by the White House.   These steps include improving domestic manufacturing of critical medicines and active pharmaceutical ingredients, increasing investments in sustainable domestic supply chains, and better monitoring of supply chain disruptions, the Biden administration said.   On Monday, the Biden administration released a report of findings f...
  • Regulatory NewsRegulatory News

    Biden’s first budget request seeks $6.5 billion for FDA

    The US Food and Drug Administration (FDA) is seeking $6.5 billion in funding for FY2022 under President Joe Biden’s $6 trillion budget proposal announced on Friday, an overall increase of $477 million (8%) over the agency’s FY2021 budget.   In a news release, the agency said the $6.5 billion budget would be used for “investments in critical public health infrastructure, core food safety and medical product safety programs and other vital public health programs,” which ...
  • Regulatory NewsRegulatory News

    Global medicinal supply chain examined in EC, US efforts

    The European Commission has launched a structured dialog addressing pharmaceutical supply chain initiatives, aiming to safeguard the security of the European Union’s supply of medicines. A 26 February launch meeting kicked off the structured dialog initiative, which brings together national authorities, patients, nongovernmental organizations working in the health sector and members of the research community.   By coming to a clearer understanding of how global medical...
  • Regulatory NewsRegulatory News

    Biden’s day one regulatory freeze

    Newly inaugurated President Joe Biden wasted little time in acting to halt former President Donald Trump’s “midnight regulations” and to revoke some of his predecessor’s controversial deregulatory orders in his first day in office.   Biden’s “regulatory freeze” memorandum will likely impact several moves by the Department of Health and Human Services (HHS) in the final days and weeks of the Trump administration that impact the US Food and Drug Administration (FDA), e...
  • Regulatory NewsRegulatory News

    Billion-Dollar Cancer ‘Moonshot’ Plan Includes $75M in New Funds for FDA

    The White House’s $1 billion proposal to fund Vice President Joe Biden's “Moonshot” cancer initiative also includes several proposed investments in federal agencies, including $75 million for a new center at the US Food and Drug Administration (FDA). President Barack Obama’s State of the Union address singled out Biden as the leader of the expansive initiative that so far has few details, and which has raised some serious doubts from cancer researcher Vinay Prasad (who...