The new system is expected to expedite research reviews without changing safety standards. U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced the agency has launched a…
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FDA Issues Guidance to Reduce Primate Testing in Drug Trials
Agency outlines updated approach for certain monoclonal antibody studies. The Food and Drug Administration (FDA) recently released a draft guidance proposing reduced reliance on non-human primates in “preclinical…
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FDA Proposes Updates to Clinical Trials
The drafted guidance would modernize the trials to be more efficient and reliable. The U.S. Food and Drug Administration (FDA) has released a draft guidance that provides updated…
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Moderna to Have 20M Vaccines by Year End
They are “actively preparing” for the vaccine launch. Coronavirus vaccine maker Moderna Inc. received an additional $472 million from the U.S. Biomedical Advanced Research and Development Authority to…
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