Kevin Madagan

Kevin Madagan

Reed Smith

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FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal

On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is...more

1/18/2017 - CLIA Clinical Laboratories CMS Diagnostic Tests FDA Laboratory Developed Tests

Radiopharmacies Celebrate the New Year with Long-Awaited FDA Guidance

On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by...more

1/3/2017 - Draft Guidance FD&C Act FDA Radiopharmaceuticals

21st Century Cures Act: Key Provisions of Interest to Drug/Device Clients

Included in the many provisions contained in the 21st Century Cures Act are ones addressing drug, device, and biologic development and approval. Topics include the use of “real world evidence” in regulatory approvals, drug...more

12/27/2016 - 21st Century Cures Initiative FDA Health Care Providers Health Information Technologies Innovation Medical Devices Medical Research Popular

HHS Agenda Signals FDA’s Intent to Issue Proposed DSCSA Rules in December 2016

FDA intends to issue long-awaited proposed regulations governing the licensing of prescription drug wholesale distributors and third-party logistics providers (“3PLs”) this December, according to the updated 2016 HHS...more

6/14/2016 - Drug Distribution Drug Wholesaling DSCSA FDA HHS Licensing Rules Prescription Drugs Regulatory Agenda Third-Party Service Provider

Navigating the Regulatory Issues of 3D Printing

The increasing popularity of 3D printing is changing the future of health care far more dramatically than we would have ever imagined. Although we have blogged about 3D printing, and the Reed Smith white paper, “3D Printing...more

3/17/2016 - 3D Printing Additive Manufacturing FDA FDA Approval Manufacturers Medical Devices Prescription Drugs

Changes to Google Ad Policy to Affect Pharmaceutical Industry; Requires Immediate Action to Paid Search Ads

Google has announced a new advertising policy for pharmaceutical companies that presents significant issues and dictates immediate changes. Effective July 20, pharmaceutical companies can no longer run pharmaceutical ads in...more

7/20/2015 - Black Box Warnings FDA Google Internet Marketing Online Advertisements Pay-Per-Click Pharmaceutical Industry Prescription Drugs Search Engines

Is Your SEM FDA Compliant? New Google SEM Policy Forces Pharmaceutical Industry to Adjust Paid Search Advertisements

Upcoming changes to Google AdWords’ ad formats will have a significant impact on pharmaceutical companies that engage in paid search advertising. In a letter to its major media agencies last month, Google announced that it...more

7/20/2015 - Advertising Black Box Warnings Disclaimers FDA Google Internet Marketing Online Advertisements Pay-Per-Click Pharmaceutical Industry Prescription Drugs Product Labels Search Engines Warning Labels

FDA Helps Dispensers Enjoy the Summer with Generous DSCSA Compliance Policy

The federal Food and Drug Administration (FDA) just announced that the Drug Supply Chain Security Act (DSCSA) deadline of July 1, 2015 for dispenser requirements related to capturing and maintaining pedigree information will...more

7/8/2015 - DSCSA FDA New Guidance Pharmaceutical Industry Prescription Drugs Suppliers Supply Chain

Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon (3rd Edition)

In this edition: - Introduction - Advertising & Marketing - Brand Protection & Reputational Management - Copyright (EU) - Copyright (U.S.) - Data Privacy & Security -...more

4/24/2014 - Copyright Cybersecurity Data Protection EU FDA Social Media Trademarks UK

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