• 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...
  • Senator Looks to Bypass FDA and Remove Zohydro With Legislation

    A US senator is calling for the US Food and Drug Administration's (FDA) to ban a recently approved pure hydrocodone painkiller known as Zohydro ER (hydrocodone bitartrate), not through a letter or request, but by legislation. Background FDA approved Zohydro ER in October 2013. The approval decision was seen by many as surprising, as it followed an FDA advisory committee meeting at which a majority of the committee members voted against approving the drug, citing its pot...
  • Pressure Mounts on DHHS to Overturn FDA Decision on Zohydro

    A senator has become the second legislator in two weeks to call on the secretary of the Department of Health and Human Services (DHHS) to exercise an authority-one used only once in the agency's history-to overturn a recent regulatory decision by the US Food and Drug Administration (FDA). Background: Zohydro That regulatory decision was with regard to Zohydro ER (hydrocodone bitartrate), a pure hydrocodone pill approved by FDA on 25 October 2013. The approval decision w...