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FDA Issues Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

On Aug. 15, the Food and Drug Administration (FDA) issued new guidance aimed at assisting institutional review boards (IRBs), clinical investigators and sponsors in complying with the FDA’s informed consent requirements for...more

Challenge to the FDA's Approval of Abortion Medication

On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more

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