Amy Dow

Amy Dow

Epstein Becker & Green

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FDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials

On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more

6/5/2023  /  Clinical Trials , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Research , Pharmaceutical Industry , Prescription Drugs , Telehealth

In Response to COVID-19, FDA Extends Enforcement Discretion for HCT/Ps Requiring Pre-Market Review

On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the...more

7/28/2020  /  FDA Approval , Food and Drug Administration (FDA) , Health Care Providers , Investigational New Drug Application (IND) , Pharmaceutical Industry , Premarket Approval Applications , Prescription Drugs , Public Health Service Act , Regenerative Medicine

FDA Seeks Public Comment on Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved...

On March 3, 2014, the U.S. Food and Drug Administration ("FDA") made available for comment a revised draft of its "Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended...more

3/11/2014  /  Drug Approvals , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Prescription Drugs
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