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

• Don’t You Forget About Me: FDA Kicks off 2018 with Letters on Promotional Activities 
• Top 5 Reasons for Life Sciences Companies to Use International Arbitration for Intellectual Property Disputes 
• Checklists and Guidance from FDA on the Acceptance Criteria for 510(k) Submissions 
• It’s the Journey, Not Just the Destination: FDA Says Have a Procedure, Use the Procedure, or Go Back and Do It from the Beginning

 Industry Insights

PHARMACEUTICALS

Don’t You Forget About Me: FDA Kicks off 2018 with Letters on Promotional Activities
By: Alan G. Minsk and Elizabeth A. Mulkey

FDA’s Office of Prescription Drug Promotion (OPDP) issued only five letters in 2017 (compared to eleven in 2016 and nine in 2015). This relatively slow year left some prescription drug manufacturers wondering if, to quote the classic Simple Minds 1980s song, FDA would “call their names, or walk on by” promotional activities that might have previously drawn a Warning Letter or Untitled Letter. In February, the agency reassured industry that it hasn’t forgotten about promotional activities, issuing one letter from OPDP, and one from the Center for Biologics Evaluation and Research (CBER). More > 

Top 5 Reasons for Life Sciences Companies to Use International Arbitration for Intellectual Property Disputes
By: Gene M. Burd

Arbitration continues gaining popularity for resolution of cross-border disputes. A 2013 PricewaterhouseCoopers survey shows that 52% of the respondents preferred international arbitration to court litigation and mediation. Over the past 10 years, the number of new cases in most of the major arbitration institutions grew, with some reporting almost a four-fold increase. The International Chamber of Commerce (ICC), for instance, reported a record 2016 year for new arbitrations with 966 new cases, which is up from 801 cases in the previous year and 793 cases in 2010. ICC also reported a record number of pending cases in 2017, suggesting that the upward trend will continue. More >

DEVICES

Checklists and Guidance from FDA on the Acceptance Criteria for 510(k) Submissions
By: Deborah L. Livornese and Kalie E. Richardson

FDA recently issued a final guidance on the Refuse to Accept Policy for 510(k)s (Guidance). The Guidance outlines the procedures and criteria FDA uses to determine whether a medical device premarket notification (510(k)) submission is administratively complete and should be accepted for substantive review. The criteria for traditional, special, and abbreviated 510(k) submissions are covered by the Guidance. The Guidance also includes, as appendices, the Acceptable Checklists FDA will use to evaluate all 510(k) types. More >

It’s the Journey, Not Just the Destination: FDA Says Have a Procedure, Use the Procedure, or Go Back and Do It from the Beginning
By: Deborah L. Livornese

The Food and Drug Administration recently posted a Warning Letter issued to a medical device manufacturer following a facility inspection citing a laundry list of alleged violations related to the company’s Corrective and Preventative Action (CAPA) procedures and Quality System Regulations (QSRs) processes. More >