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   October 2013

Arnall Golden Gregory LLP's (AGG) 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



A Review of Summer FDA Enforcement Against Unlawful Drug Product Promotion
By: Alan G. MinskKelley C. Nduom and
Sari N. Bourne

The summer season did not slow down the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) from taking enforcement actions against perceived unlawful product promotion. A review of recently-issued enforcement letters offers insight into some of OPDP’s concerns, which companies should consider when developing promotional materials. More >



A Medical Device Company's Guide to the New Unique Device Identification (UDI) System
By: Emalee G. Murphy and Sari N. Bourne

On September 24, 2013, the Food and Drug Administration (FDA) issued a Final Rule regarding a new way manufacturers must label and classify devices. According to the new system, called the unique device identifier system, each device's label and package must bear a UDI unless an exception or alternative applies. The Final Rule is accompanied by a draft guidance further explaining the new system's database, entitled "Global Unique Device Identification Database" (GUDID).  More >

FDA Issues Guidance for Mobile Medical Applications
By: William H. Kitchens and Kimberly T. Bond 

The number of mobile medical applications for use on smartphones and tablets is growing rapidly as more and more app developers release new products in this area. However, until recently, the regulatory status of many of these mobile applications has been unclear. Some of the uncertainty will be eliminated by FDA’s issuance of a nonbinding final guidance document concerning mobile medical apps on September 25, 2013. More



House Bill Would Provide 15-Year Market Exclusivity for Eligible Drugs and Biologicals and Promote Innovative Diagnostic Tests
By: Emalee G. Murphy and Sari N. Bourne

On September 12, 2013, Representative Leonard Lance (R-NJ) reintroduced H.R. 3091, "Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013," which would, among other things, create a new 15-year exclusivity period for certain drugs indicated for life-threatening and serious conditions and extend exclusivity for drugs and biologics associated with new innovative diagnostics.  More >

Industry Activities and Recognition

Bill Kitchens Quoted in Law360 Article on Legislation Regarding Compounded Drugs

AGG Partner William H. Kitchens was quoted in a Law360 article on October 1, 2013, which reported on the Drug Quality and Security Act, H.R. 3204, introduced in the House of Representatives on September 27, 2013. The new legislation reflects a bipartisan, bicameral agreement with the Senate Health, Education, Labor, and Pension leadership and addresses both the safety of compounded drugs and FDA’s oversight over compounding and establishes for the first time a uniform system to trace and track drugs to prevent counterfeits from entering the pharmaceutical supply chain. More >

Emalee Murphy Quoted in Silver Sheet Article on Meetings with FDA

AGG Partner Emalee G. Murphy was quoted in the Silver Sheet, a leading publication for medical device quality control issues. She provided guidance for companies seeking meetings with FDA. More >  

Upcoming Events 

Alan G. Minsk will be a panelist discussing "Dealing with Outbreaks of Food-Borne Illness" at the FDLI’s CDC & FDA: Collaboration & Challenges Conference in Atlanta, GA on October 23, 2013.

Alan G. Minsk will present "Critical Updates for Medical Device Reporting" at the Israel Chapter of Regulatory Affairs Professionals Society's Critical Regulatory Updates event in Ramat HaSharon, Israel on November 5, 2013.

Alan G. Minsk will present "Challenges and Opportunities When Communicating With The Food and Drug Administration" at the SCBIO FacetoFace Annual Conference in Charleston, SC on November 14, 2013.

Alan G. Minsk will co-present on "Unapproved Uses, DTC Advertising, Social Media and Emerging Theories in the Regulation of Off Label Promotion" at the FDA Intensive Conference, sponsored by the Momentum Event Group in Washington, DC on November 18, 2013.

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.
©2013. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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