A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...
Two Republican lawmakers were invited to attend a Food and Drug Administration meeting about the potential expanded approval ...
Kaiser Health News interviewed Robert Califf, MD, former FDA commissioner, concerning his thoughts on the drug approval process and the current presidential administration’s outlook on quickening the ...
Pazdur, who has worked at the FDA for 26 years, told senior leaders on Tuesday that he plans to step down, just weeks after ...
Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated ...
Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several ...
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a ...
Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
A system allowing drugs to be approved in the UK by other “trusted” regulators such as the US Food and Drug Administration (FDA) is sparking concern among experts. They say the strategy risks lowering ...
The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...
A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging ...
DENVER — A "huge" number of life-years is being unnecessarily lost because of delays in cancer drug approvals, according to research presented here at the 16th World Conference on Lung Cancer. Every ...
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