Michael A. Swit

Michael A. Swit

Duane Morris LLP

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FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do

On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved...more

11/12/2013

Mobile Medical Apps Guidance

Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration ("FDA") published its...more

10/7/2013 - FDA Mobile Apps Mobile Devices Telemedicine

FDA Draft Guidance Details Key Cybersecurity Management Measures Expected in Medical Device Submissions

Last month, the U.S. Food and Drug Administration (FDA) issued its Draft Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Recognizing the increasing need for effective...more

7/18/2013 - Cybersecurity FDA Medical Devices Mobile Devices Risk Management

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

3/6/2013 - Affordable Care Act CMS Healthcare Manufacturers Medical Devices Pharmaceutical Physicians Reporting Requirements Research Funding Sunshine Act

FCC Releases Decision on New Funding Program for Rural Health: Broadband Connectivity Prioritized and the Expansion of...

Federal Communications Commission (FCC; the "Commission") decision making continues to be active in the area of telemedicine. Recently, on December 21, 2012, the agency released a lengthy decision updating its rules and...more

1/3/2013 - Broadband Digital Health FCC Healthcare mHealth Rural Health Care Program Telemedicine

AliveCor Veterinary ECG Model Paves FDA-Friendly Path to the Market

Originally published in mHealth Newsletter on November 14, 2012 In a recent move that mobile medical application developers may want to emulate, AliveCor—the developer of a mobile electrocardiogram (ECG) system awaiting...more

11/15/2012

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