Ralph S. Tyler

Ralph S. Tyler

Venable LLP

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Latest Posts › FDA

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Protecting Drug Supply Chain Security

Millions of Americans take prescription drugs every day while assuming that those drugs are what they purport to be, that they have not been tampered with, and certainly that they are not counterfeit. The validity of those...more

6/13/2014 - DSCSA FDA FDCA Manufacturers Pharmaceutical Prescription Drugs Supply Chain

The Warning Letter Is Only the Start

So you’ve had a bad day — FDA has told you to stop marketing your product. The good news, things can only get better, right? Maybe not if a class action follows hot on the heels of FDA’s order. This, in brief, is the...more

1/27/2014 - 23andMe Class Action False Advertising FDA Misleading Statements Warning Letters

FDA’s Message to Medical Device Company: Stop

The widely publicized start-up company 23andMe, Inc. markets its “personal genome service product” as providing reports on hundreds of diseases and conditions that enable users to “take steps toward mitigating serious...more

11/29/2013 - 23andMe FDA FDCA Genetic Testing Medical Devices

Business News Digest – September 2013

In this issue: - What to Expect When You're Selling Your Company – Indemnification - Association Membership and Program Restrictions and the Antitrust Laws: Don’t Stumble Out of the Gate - CFPB: July...more

9/9/2013 - Antitrust Provisions Attorney Disbarrment Brand CFPB China Dietary Supplements Discipline Enforcement Actions FDA Federal Funding Federal Grants Food Labeling Food Safety Non-Profits Nutritional Supplements Sales SEC Supply Chain

Advertising News & Analysis - August 29, 2013

In this issue: - Register Now and Join Us at ERA D2C - What You Think You Know Can Hurt You - FDA Serves Seconds on Medical Food Guidance - Facebook Promotions? You Don't Need an App for That -...more

9/2/2013 - Advertising FDA FTC Medical Foods NAD Social Media

FDA Serves Up Another Helping of Draft Guidance on Medical Foods

On August 13th, the Food and Drug Administration (FDA) released a second version of its draft guidance on medical foods. The draft guidance, “Frequently Asked Questions About Medical Foods; Second Edition,” amends and expands...more

8/28/2013 - FDA Food Labeling Healthcare Medical Foods Physicians

Food for Thought: Understanding FDA's Proposed Rules for Importers of Food and Dietary Supplements and How They May Impact Your...

With approximately 15% of all food consumed in the United States coming from overseas, the U.S. Food and Drug Administration (FDA) has renewed its focus on imported food safety and now seeks to place risk-based preventive...more

8/14/2013 - FDA Food Labeling Food Safety Foreign Suppliers FSMA Proposed Regulation

Business News Digest – February 2013

In this issue: - What You Need to Know About the Proposed Maryland Investment Tax Credit for Cybersecurity - Trade Secret Legislation May Increase Infringement Claims and Lead to a Private Right of Action -...more

2/20/2013 - Antitrust Conspiracies CIPA Class Action Class Certification Cybersecurity Department of Transportation ECPA FDA Food Safety Infringement Investment Tax Credits IRS NEPA Pay or Play Trade Secrets Voluntary Correction Program

Advertising News & Analysis - January 17, 2013

In this issue: - FTC Adds New Commissioner - Balance, Clarity Key to Success of Class Action Waivers - FDA’s Proposed Food Safety Rules Focus on Prevention - WhoNu Dueling NAD, CARU Inquiries Would...more

1/23/2013 - Advertising Amazon Apple Arbitration Agreements CARU Class Action FDA Food Safety FTC NAD Sales Contracts Waivers

FDA Shifts Focus to Prevention with Publication of Proposed Food Safety Rules

On January 4th, the U.S. Food and Drug Administration (FDA) published two long-awaited proposed food safety rules aimed at preventing foodborne illness. The proposed rules implement the 2011 Food Safety Modernization Act...more

1/16/2013 - Farms FDA Food Contamination Food Manufacturers Food Safety FSMA Regulatory Standards Safety Precautions

Advertising News & Analysis – December 13, 2012

In this issue: - It’s Easier Being Green - Off-Label Marketing Protected by First Amendment - Understanding New Restrictions on Advertising GI Bill Benefits - FTC Looks at "The Big Picture" - Upcoming...more

12/17/2012 - Advertising Commercial Speech FDA FDCA Free Speech FTC GI Bill Green Guides Marketing Off-Label Promotion Off-Label Use Pharmaceutical

Advertising News & Analysis – December 6, 2012

In this issue: - Appeals Court Says First Amendment Trumps FDA Off- Label Marketing Rules - FTC Announces 100th Do Not Call Enforcement Action - NuWave v. Emson Highlights Infomercial Copyright and Trademark...more

12/11/2012 - Advertising Do Not Call List FDA FTC Off-Label Promotion

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