Earlier this year, when the FDA asked Amgen to pull its rare disease drug Tavneos from the market, the California drugmaker ...
The U.S. Food and Drug Administration's Center for Drug Evaluation and Research on Monday proposed withdrawing approval of ...
In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information ...
Editor's note: This article was updated on 11 January 2024 to correct a typo. The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) issued a report on the 55 novel ...
The FDA's Center for Drug Evaluation and Research, or CDER, has established a new center for communication between CDER staff and stakeholders involved in clinical trials, according to an April 15 ...
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