Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more
The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more
4/5/2020
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During the coronavirus (COVID-19) outbreak, FDA guidance allows healthcare providers to prescribe drugs subject to Risk Evaluation and Mitigation Strategies without conducting the required laboratory tests or imaging studies....more