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FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more

COVID-19 Related Medical Devices: FDA Finalizes Transition Plan Guidance

On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19...more

FDA Drafts Public Health Emergency Transition Plan: What Device Manufacturers Need to Know

The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key...more

COVID-19: Provider Relief Fund General Distribution – Phase 3

On October 1, 2020, the Department of Health and Human Services (HHS) announced a new $20 billion Phase 3 of the Provider Relief Fund (PRF) General Distribution. Much like the Phase 2 funding, Phase 3 funding will be made...more

COVID-19: HHS Publishes Long-awaited Reporting Requirements for Provider Relief Fund Recipients

On September 19, 2020, the Department of Health and Human Services (HHS) released guidance establishing the reporting requirements for health care providers that received Provider Relief Fund (PRF) payments. These reporting...more

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