Amy Dow

Amy Dow

Epstein Becker Green

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Latest Publications


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 FDA NIH Proposed Regulation Public Health Service Act Registration Reporting Requirements Rulemaking Process

FDA Releases Draft Guidance Updating Agency Policies on the Informed Consent Process for Clinical Trials

On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more

9/25/2014 - Clinical Trials Disclosure Requirements Draft Guidance FDA Informed Consent

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more

6/25/2014 - Advertising Biotechnology FDA Healthcare Life Sciences Medical Devices Pharmaceutical Industry Popular Social Media

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more

6/7/2014 - Certiorari Dismissals False Claims Act (FCA) Healthcare Fraud Medicare Off-Label Use Pharmaceutical Industry Pleading Standards Popular Qui Tam Rule 9(b) SCOTUS Split of Authority Takeda Pharmaceuticals Whistleblowers

FDA Seeks Public Comment on Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved...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

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