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  February 2015

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

In this Issue

 Industry Insights



There Must Be Some Misunderstanding: FDA Issues New Guidance On Disclosing Risk Information In Consumer-Directed Print Advertisements And Promotional Labeling For Human Prescription Drugs

The rock band Genesis sang in its 1980-released hit song, “Misunderstanding,” “There must be some misunderstanding; there must be some kind of mistake.” Someone at the Food and Drug Administration must be a fan of the song, as the agency recently issued a revised draft guidance entitled, “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisement and Promotional Labeling for Human Prescription Drugs.” This guidance follows the agency’s 2004 draft after receiving industry feedback and conducting its own research. Comments are due 90 days from the date the guidance is issued in the Federal Register. More >

Recent Court Decision Clarifies Some 505(b)(2) NDA Issues and What It Might Mean for Industry

In January 2015, the United States District Court of the District of Columbia issued an opinion, supporting the Food and Drug Administration’s (FDA) positon on a 505(b)(2) new drug application (NDA) approval. The decision reaffirms FDA’s interpretation of the statutory provision (section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDC Act)), which allows an applicant to rely on clinical studies that were previously submitted to the agency in support of another drug and not conducted or licensed by the 505(b)(2) applicant. More >

Expanded Access to Unapproved Drugs Recast: FDA Simplifies Compassionate Use Application Process

On February 10, 2014, the Food and Drug Administration (FDA) announced in the Federal Register the release of a new draft guidance that makes changes to its “compassionate use” process to allow a simpler way for licensed physicians to seek expanded access for their patients to drugs that have not yet been approved by FDA as safe and effective. The draft guidance introduces and describes draft Form FDA 3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND)), which is commonly known as a compassionate use request. When finalized, draft Form FDA 3926 will be available for licensed physicians to use for expanded access requests for individual patient INDs. More >



No Sweat: FDA Doesn’t Intend to Regulate Low-Risk General Wellness Products

The Food and Drug Administration has issued a draft guidance entitled, “General Wellness: Policy for Low Risk Devices.” The agency describes its enforcement policy as it relates to low-risk medical devices that “promote a healthy lifestyle,“ which FDA refers to as “general wellness products.” The bottom line is that the agency does not intend to evaluate whether these types of products are “medical devices,” subject to its regulation, or, if they qualify as devices, whether they comply with those requirements applicable to medical devices, such as marketing authorization, establishment registration and listing, labeling, Quality System Regulations, and Medical Device Reporting. More >

Industry Activities and Recognition

William Kitchens Lectures at the Georgia Institute of Technology

William H. Kitchens will present a lecture on FDA regulation of pharmaceuticals on March 12, 2014 at the Georgia Institute of Technology as part of a semester class on drug discovery, design, manufacture, and delivery.

Michael Burke Launches Irish Export Insights Blog

Michael E. Burke launched a blog entitled "Irish Export Insights: Practical Guidance for Irish and Northern Irish Companies on Doing Business in the U.S." This blog will help Irish and Northern Irish companies understand and mitigate the potential operational risk of exporting or expanding to the U.S. More >

Alan Minsk Published in Corporate Counsel

Alan G. Minsk was published in the Corporate Counsel in an article entitled "To Correct or Not to Correct Social Media Misinformation" discusses the FDA draft guidance document "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices".  More >

Upcoming Events 

AGG Partner, Alan G. Minsk, will present “Drugs and Biologics: Labeling” at the American Conference Institute FDA Boot Camp on March 10, 2015 in New York, NY.

AGG Partner, Alan G. Minsk, will present “Compliance – It’s the Law and it’s Good Business” at the 39th International Good Manufacturing Practices Conference on March 12, 2015 in Athens, GA.

AGG Partners Tenley A. Carp and Jeffrey Y. Lewis will present a complimentary webinar "Doing Business in the US: What Foreign Companies Need to Know About Government Contracts and Civil Litigation" on April 29, 2015. 

This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and Public Policy Practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information about the Food and Drug Practice, please contact Alan Minsk.
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