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...
by Jordana Choucair | Sep 13, 2022 | Life Sciences
The Food and Drug Administration (FDA) will consider Perrigo Co. PLC’s application to make its daily birth control pill available over the counter during a joint meeting on November 18. If the FDA’s Nonprescription Drugs Advisory Committee and Obstetrics,...
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