Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity
No improvement seen in representation of Black patients after implementation of a 2015 FDA action plan to improve diversity
Condom was approved through the De Novo premarket review pathway for low- to moderate-risk devices of a new type
Throat swabs are common in some countries, but most self-tests in the United States require nasal samples
Similar time window for boosters is already in place for people who received the Pfizer/BioNTech vaccine.
Agency says that antigen tests ‘do detect the omicron variant, but may have reduced sensitivity’
If confirmed by the Senate, Califf will direct an agency responsible for more than $2.8 trillion worth of food, medical products, and tobacco
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