by Jordana Choucair | Sep 26, 2022 | Life Sciences
Moderna announced that it asked the Food and Drug Administration (FDA) to authorize its omicron booster shots for children. Moderna filed two separate FDA authorization requests, one for adolescents ages 12 to 17 and another for kids ages 6 to 11. The biotech company...
by Jordana Choucair | Sep 23, 2022 | Life Sciences
Senate and House health committee leaders reached an agreement on a five-year reauthorization of the Food and Drug Administration’s (FDA) user fee. The renewal will be part of the short-term continuing resolution, which Congress must pass by October 1 to avoid a...
by Jordana Choucair | Sep 22, 2022 | Life Sciences
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report suggesting that the Food and Drug Administration’s (FDA) emergency use authorization (EUA) policies resulted in quality issues and false results with...
by Jordana Choucair | Sep 22, 2022 | Life Sciences
The Centers for Disease Control and Prevention (CDC) said the agency expects that the reformulated COVID-19 boosters from Moderna Inc. and Pfizer Inc.-BioNTech SE will be available for children by the middle of next month. The CDC said it could issue its...
by Jordana Choucair | Sep 16, 2022 | Life Sciences
A New York Times article provides insight into the Food and Drug Administration (FDA) prescription drug user fee debate as Congress works toward finalizing a bill by September 30. While critics of the program say it gives the drug and medical device industry too much...
by Jordana Choucair | Sep 15, 2022 | Life Sciences
The White House is planning to allocate $2 billion to launch President Biden’s new national biomanufacturing initiative. According to a press release, the administration will invest $1.7 billion to expand domestic biomanufacturing: the Department of Defense (DoD) will...
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