Tag Archives: Food and Drug Administration

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading” statements about off-label uses for its omega-3 drug, Vascepa, violated Amarin’s right to engage in constitutionally protected speech. The underlying claims and settlement may have … Continue reading this entry

FDA Unveils Action Plan to Combat Opioid Abuse

Research
The U.S. Food and Drug Administration (“FDA”) recently announced a “far-reaching action plan” to evaluate and improve the agency’s prescription opioid policies. The announcement came amidst public criticism and mounting political pressure on the FDA to address the country’s “opioid abuse epidemic,” including a hold placed by Senate Democrat Edward J. Markey on President Obama’s … Continue reading this entry

Laboratory Developed Tests Emerging in FDA Regulation

Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer, heart disease and diabetes. As practitioners become increasingly reliant on diagnostic tests to guide important treatment decisions, concerns about the … Continue reading this entry

mHealth Technology – Development in an Uncertain Regulatory Climate

mHealth
The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies or “mHealth” technologies and applications can allow patients to better manage their own health and wellness, and provides patients and providers with … Continue reading this entry

FDA Outlines 'Anticipated Details' of New Oversight Approach for Laboratory Developed Tests

Regulatory-Developments
Laboratory Developed Tests (LDTs) are tests that are intended for clinical use and designed, manufactured and used within a single laboratory. On July 31, 2014, the federal Food and Drug Administration (FDA) provided advance notice to Congress (as required by statute) of its intent to issue draft guidance for the regulatory oversight of LDTs, after … Continue reading this entry

Supreme Court Holds That Lanham Act False Advertising Claims Are Not Preempted by FDCA

Last week, on June 12, 2014, the U.S. Supreme Court unanimously held that a Lanham Act false advertising case may be brought even if Food and Drug Administration (FDA) beverage labeling regulations permit use of the challenged claim. Reversing the Ninth Circuit, the Court held in POM Wonderful LLC v. The Coca-Cola Company, that the … Continue reading this entry

FDA Announces Plan for Expedited Review of Certain Medical Devices

The Food and Drug Administration (FDA) published proposed guidance on April 22nd for a voluntary expedited access program for new high-risk medical devices that are intended to treat or diagnose patients with serious conditions that are unaddressed by approved technology. The guidance, titled “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need … Continue reading this entry

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the “Agencies”) published their long-awaited report, FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework. The report, mandated by the Food and Drug … Continue reading this entry