Amy Dow

Amy Dow

Epstein Becker & Green

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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

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

12/9/2014  /  Clinical Trials , Food and Drug Administration (FDA) , National Institute of Health (NIH) , Proposed Regulation , Public Health Service Act , Registration , Reporting Requirements , Rulemaking Process
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