Arnall Golden Gregory LLP

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171 17th Street NW
Suite 2100
Atlanta, GA 30363, United States
Phone: 404.873.8500
Areas of Practice
  • Alternative Dispute Resolution (ADR)
  • Antitrust & Trade Regulation
  • Art, Entertainment, & Sports Law
  • Bankruptcy
  • Business Organizations
  • Commercial Law & Contracts
  • Communications & Media Law
  • Criminal Law
  • Debtor/Creditor
  • Energy & Utilities
  • Environmental Law
  • Finance & Banking
  • Government
  • Health
  • Immigration Law
  • Intellectual Property
  • International Law & Trade
  • Labor & Employment Law
  • Litigation
  • Mergers & Acquisitions
  • Privacy
  • Real Estate
  • Science, Computers, & Tech
  • Securities Law
  • Taxation
  • Transportation
  • Wills, Trusts, & Estate Planning
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Locations
Other U.S. Locations
  • D.C.
  • Georgia
Number of Attorneys
100+ Attorneys

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating…more
 /  Health, Science, Computers, & Technology

Filing Review is About More Than Checking the Boxes; or Is It?

Things sometimes change fast. Our original article described one company’s recent announcement that the Food and Drug Administration refused to file its new drug application as a reminder that the agency’s filing review may be…more
 /  Health

FDA Announces “Unique” Restriction on Approved Medical Device

On April 9, 2018, the Food and Drug Administration announced an additional “unique type of restriction” on the sale and distribution of an approved medical device. FDA issued an order requiring healthcare providers and…more
 /  Health

CMS to Use Enforcement Discretion to Help States Comply with the Medicaid Home Health Final Rule

On April 5, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Informational Bulletin regarding compliance with the Medicaid Home Health Final Rule (the “Medicaid HH Final Rule”). The Medicaid HH Final Rule was…more
 /  Health

Will China-Specific Tariffs Impact Irish/NI Exports to US?

My last post discussed the potential (but likely very small) impact of the relatively new U.S. steel and aluminum tariffs on Irish and Northern Irish exports to the U.S. In this post, I turn to the related question of whether…more
 /  International Law & Trade

Court Dismisses FTC Antitrust Lawsuit Alleging That Shire ViroPharma Inc. Abused Government Processes to Delay Generic Competitors

In recent years, the Federal Trade Commission (FTC) has brought a series of cases involving drug manufacturers allegedly seeking to delay competition from generic drug companies. See, e.g., F.T.C. v. Actavis, Inc., 570 U.S. 136…more
 /  Antitrust & Trade Regulation, Health, Science, Computers, & Technology

FDA Delays Enforcement of the Postmarketing Safety Reporting (PMSR) Final Rule

The Food and Drug Administration issued a final rule setting forth postmarketing safety reporting (PMSR) requirements for combination products subject to premarket review by FDA on December 20, 2016. For some of these…more
 /  Health

Compliance News Flash

Arnall Golden Gregory LLP is pleased to provide you with the Compliance News Flash, brought to you each Friday. This weekly update is your source for timely background screening and immigration-related news that is important to…more
 /  Consumer Protection, Immigration Law, Labor & Employment Law, Privacy, Science, Computers, & Technology

US Aluminum/Steel Tariffs and Irish/NI Companies

Several Irish and NI companies have asked me whether the recently-imposed US tariffs on aluminum and steel would impact their products–products that use/incorporate aluminum and steel. Much of the confusion stems from how the…more
 /  Elections & Politics, International Law & Trade

New CMS Medicare Advantage Policy Could Have Significant Impact on Senior Living and In-Home Care Providers

A Centers for Medicare & Medicaid Services (CMS) call letter (the “Call Letter”) released on April 2, 2018, could mean a dramatic and positive shift in CMS policy related to Medicare Advantage (MA) plans and senior living and…more
 /  Health

Hospice Medical Directors: How Many Is Too Many?

According to recent guidance from the Centers for Medicare & Medicaid Services (CMS) Region V, having more than one Medical Director for each hospice provider number could lead to sanctions, including termination. On January 12,…more
 /  Health

Fifth Circuit: District Courts Have Jurisdiction to Halt Medicare Recoupments Pending Administrative Appeal to Prevent Procedural Due Process Violations

Medicare’s implementation of post-payment review through private contractors who are overly aggressive in denying payments, combined with an ineffective review process at the first two levels of administrative appeal…more
 /  Health

How to Open a U.S. Bank Account

Just back from a two-week swing through Belfast, Antrim (at a wonderful InvestNI program) Londonderry/Derry, Galway, and Dublin, meeting with companies looking to export to the U.S. One question that came up time and again: how…more
 /  Commercial Law & Contracts, Finance & Banking, International Law & Trade

E-Verify Has a New Look

The U.S. Citizenship and Immigration Services rolled out an updated website for E-Verify. E-Verify is a web-based system that allows enrolled employers to confirm the eligibility of their employees to work in the United…more
 /  Immigration Law, Labor & Employment Law

Proposed Vermont Bill Would Implement Examination of Change of Ownership Requirements for Nursing Facilities

Nursing facilities undergoing changes of ownership (CHOW) in Vermont could see new requirements starting in 2019 if a recent bill is passed. The state, which currently can take as long as one year (or more in some cases) to…more
 /  Health
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