Daniel G. Gottlieb

Daniel G. Gottlieb

Epstein Becker Green

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FDA Releases Draft Guidance Updating Agency Policies on the Informed Consent Process for Clinical Trials

On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process.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9/25/2014 - Clinical Trials Disclosure Requirements Draft Guidance FDA Informed Consent

CMS Requests Comments on the Dispute Resolution Process Associated with the Physician Payment Sunshine Act

On May 5, 2014, the Centers for Medicare & Medicaid Services ("CMS") announced an opportunity to submit comments on the dispute resolution and correction procedures proposed in the final rule on the Open Payments reporting...more

5/9/2014 - Affordable Care Act CMS GPOs Hospitals Physician Medicare Reimbursements Physicians Public Comment Sunshine Act

FDA Seeks Public Comment on Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved...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

Second Circuit Rules That Certain Speech Regarding the Off-Label Use of Drugs Is Protected Under the U.S. Constitution

In a long-awaited decision, on December 3, 2012, a divided panel (2–1) of the U.S. Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia, a former pharmaceutical sales representative for Jazz...more

12/13/2012 - Commercial Speech FDA FDCA Free Speech Marketing Off-Label Promotion Off-Label Use Pharmaceutical

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