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 Food and Drug Newsletter    

June 13, 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
 

Pharmaceuticals

An Ounce of Prevention: FDA Issues Guidance on Contract Manufacturing Arrangements for Drugs
By: Alan G. Minsk, Lynn S. Scott and Kelley C. Nduom

In late May, FDA published a draft guidance entitled, Contract Manufacturing Arrangements for Drugs: Quality Agreements, to clarify the agency’s current thinking on the obligations of each entity involved in contract manufacturing of drugs and how quality agreements may be used to outline responsibilities. More >

What Every Pharma/Medical Device Company Needs to Know Now About Export Controls
By: Michael E. Burke

U.S. export controls can present a confusing, and sometimes contradictory, compliance burden on pharmaceutical and medical device companies. These regulations impact what pharmaceuticals and medical devices can be exported and with whom companies may conduct business. Penalties for export control violations can be severe. This article will discuss key U.S. export control issues affecting U.S. pharmaceutical and medical device companies, and provide practical tips on reducing export control risk. More >

 
  
 

Medical Devices

Get Back to Where You Once Belonged: FDA Wins Lawsuit to Rescind 510(k) 
By: William H. Kitchens and Alan G. Minsk

The Food and Drug Administration recently won an important court victory that allowed the agency to rescind a medical device’s premarket notification clearance (commonly referred to as a “510(k)”). The decision of the U.S. District Court for the District of Columbia is significant, because it supports the agency’s position that it has the inherent authority to rescind a 510(k). More >

 
 
 

Food

FDA Issues Final Rule on Prior Notice of Imported Food
By: Emalee G. Murphy and Kelley C. Nduom

On May 30, 2013, the Food and Drug Administration published a Final Rule requiring, in addition to the other information already mandated, that prior notices of any imported article of food identify any country where the article has been refused entry. More >

 
 

Legislative Update from Capitol Hill

Overview of 2012 and 2013 Federal Legislation Regulating Pharmacy Compounding
By: William H. Kitchens

Last month, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved the "Pharmaceutical Compounding Quality and Accountability Act," a bipartisan bill introduced by Senator Tom Harkin (D-Iowa) and other members of the HELP Committee. The bill will likely serve as the primary Senate vehicle to address pharmaceutical compounding and delineate compounding oversight responsibility between states and the U.S. Food and Drug Administration. This article compares past and current legislation in the House and Senate related to pharmacy compounding. More >

Medical Device Tax Not Likely to Disappear Without Major Tax Overhaul
By: Emalee G. Murphy

Despite indications of bi-partisan support in both the House and Senate, the 2.3 percent tax on certain medical devices, included in the Affordable Health Care legislation (PL 111-148, PL 111-152), is unlikely to disappear in this Congress. More >

 
 

Sunshine Series

Physician Payment Sunshine Act Updates
By: H.Carol SaulJennifer Downs Burgar and Lanchi Nguyen Bombalier

In an effort to assist our clients and friends with implementation of the final regulations promulgated pursuant to the Physician Payment Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act), we are providing updates in a “Sunshine Series” of articles. Our Sunshine Series provides information on the government’s preparations for information collection and publication (and eventual enforcement), practical tips for compliance, interesting nuances in the final regulations, State law preemption, and responses to general-interest questions posed by our clients.

 
 Upcoming Events

2014 Health Care Reform Webinar: What You Need to Know and Do Now to Avoid Significant Penalties.

 

 
This newsletter is published by the 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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