Approved label populations may be broader than trial populations for new drugs
1. In this cross-sectional study, approved label populations were broader overall compared to trial populations for new drugs in the ...
Tag: Food and Drug Administration (FDA)
The Scan by 2 Minute Medicine®: Veozah for Hot Flashes, Affordable Care Act Mandate for Preventive Care, Pride Month, and RSV Drug for Infants
The Scan by 2 Minute Medicine® is a pop-culture medical newsletter and exclusive benefit for 2 Minute Medicine Plus subscribers. ...
The majority of FDA-approved drug trials recruit from low- and middle-income countries
1. This study found that a high proportion of Food and Drug Administration (FDA) drug trials recruit participants from low- ...
Accelerated approval drugs incur significant fee-for-service Medicare costs
1. Medicare beneficiaries used 36 accelerated approved drugs across 55 indications, totaling $1.2 billion in Medicare fee-for-service spending in 2019. ...
Postmarket surveillance programs largest source of safety data triggering vaccine label changes
1. Postmarketing surveillance programs of Food and Drug Administration approved vaccines were the most common source of safety data triggering ...