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
See more
Locations
Other U.S. Locations
  • D.C.
  • Georgia
Number of Attorneys
100+ Attorneys

AGG Food and Drug Newsletter - September 2017

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…more
 /  Consumer Protection, Health, Science, Computers, & Technology

Recent Warning Letters from FDA about Medical Devices: Investigational Device Exemptions and Lack of Marketing Authorization are the Focus

Over the past several months, the Food and Drug Administration (FDA) has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device to…more
 /  Health

Some May Come and Some May Go: FDARA Brings Changes to User Fees and Other FDA Programs

On August 18, 2017, the President signed the FDA Reauthorization Act of 2017 (FDARA), which revises and extends several of FDA’s user fee programs. The user fee programs establish filing fees for various application types and…more
 /  Health

Dow Takes its Gene Patents Row with Bayer to the Supreme Court to Avoid the $455 Million Arbitral Award

When a company agrees to arbitrate an international patent licensing agreement, the avenues for the appeal of the resulting arbitral award are very limited. Even the invalidity or expiration of the underlying patents may be…more
 /  Intellectual Property, Science, Computers, & Technology

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good…more
 /  Health, Science, Computers, & Technology

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing what…more
 /  Communications & Media Law, Consumer Protection, Health

FDA Issues Guidance on Use of Real-World Evidence for Medical Devices

On August 31, 2017, the Food and Drug Aministration issued a final guidance titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” In the guidance, which finalizes the agency’s July 2016…more
 /  Health, Science, Computers, & Technology

Expanded Fraud and Abuse Liability under Proposed “Medicare for All” Bill

On September 13, 2017, Senator Bernie Sanders (I-VT) introduced his “Medicare for All Act of 2017” which, as the name implies, would expand Medicare to cover nearly every American. Although it is unlikely that the bill will…more
 /  Health

CMS Proposes Cancellation of Bundled Payment Initiatives

On August 15, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule (the “Proposed Rule”) that, if finalized, would (A) cancel the mandatory Episode Payment Models (“EPM Models”) and Cardiac…more
 /  Health

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and Congressional Entities Raise the Stakes for the Pharmaceutical Industry in General and for Opioid Manufacturers in Particular

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization. The…more
 /  Criminal Law, Health

CMS Grants Post-Hurricane Reporting Exceptions for Providers Impacted by Storms

Last week, the Centers for Medicare and Medicaid Services (CMS) issued an email alert notifying providers that the agency will grant exceptions under certain Medicare quality reporting and value-based purchasing programs for…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
 /  Antitrust & Trade Regulation, Elections & Politics, Finance & Banking, Immigration Law

D.C. Circuit Finds District Court Abused Discretion by Implementing a 4 Year Deadline to Clear Backlogged Administrative Appeals

On August 11, 2017, the D.C. Circuit issued its decision on the District Court’s order in American Hospital Association v. Price in a 2-1 decision, holding that the District Court abused its discretion by ordering the Secretary…more
 /  Administrative Law, Health

CMS Issues Guidance to Change Medical Reviewer Requirements for Complex Medical Reviews

Effective September 12, 2017, the Centers for Medicare & Medicaid Services (CMS) will implement changes to ensure that complex reviews for coverage determinations are performed by Registered Nurses (RNs), therapists, or…more
 /  Health

DACA Program Rescinded – What it Means For The Form I-9 And Work Authorization

The Trump Administration announced this week that it is phasing out the Deferred Action for Childhood Arrivals (DACA) program. DACA is a program that allows certain individuals who came to the United States as children, who have…more
 /  Labor & Employment Law, Immigration Law
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