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
- A Review of Summer FDA Enforcement Against Unlawful Drug Product Promotion
- A Medical Device Company's Guide to the New Unique Device Identification (UDI) System
- FDA Issues Guidance for Mobile Medical Applications
- House Bill Would Provide 15-Year Market Exclusivity for Eligible Drugs and Biologicals and Promote Innovative Diagnostic Tests
- Industry Activities and Recognition
- Upcoming Events
PHARMACEUTICALS
A Review of Summer FDA Enforcement Against Unlawful Drug Product Promotion
By: Alan G. Minsk, Kelley 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 >
MEDICAL DEVICES
A Medical Device Company's Guide to the New Unique Device Identification (UDI) SystemBy: 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 The Final Rule is accompanied by a draft guidance further explaining the new system's database, entitled "Global Unique Device Identification Database" (GUDID).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 ApplicationsBy: 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
NEWS FROM WASHINGTON
House Bill Would Provide 15-Year Market Exclusivity for Eligible Drugs and Biologicals and Promote Innovative Diagnostic TestsBy: 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
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
| 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 |