Biden Administration met its self-declared goal of launching a booster campaign ‘the week of September 20’ – but with a more complex messaging challenge than anyone could have wanted after US FDA authorization and CDC recommendation for a ‘booster’ dose of Pfizer/BioNTech’s COVID vaccine left considerable confusion about who should get a third shot.
The formal launch of a COVID-19 “booster” dose campaign in the US is clearly not taking the shape anyone expected when President Biden announced plans for a universal third-dose recommendation in mid-August.
Back then, it sounded simple: everyone in the US who had been fully vaccinated against COVID at the start of...
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
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Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
