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Overview Arnall Golden Gregory (AGG), an Am Law 200 law firm with 165 attorneys in Atlanta and Washington, DC, takes a “business sensibility” approach…
Arnall Golden Gregory LLP | USA | 21 Feb 2022
It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing
In a nod to Alice Cooper's 2000 song, "It's the Little Things" (or, for literary fans, Robert Frost's quote, "It's the little details that are vital…
Arnall Golden Gregory LLP | USA | 14 Feb 2022
OIG’s First Advisory Opinion of 2022 Allows for Expansion of Discount Programs
On January 19, 2022, the Department of Health and Human Services, Office of Inspector General ("OIG") released a favorable Advisory Opinion, OIG…
Arnall Golden Gregory LLP | USA | 28 Jan 2022
Freeze-Frame: FDA Issues an Untitled Letter for an Unlawful Instagram Post
Does anyone remember the 1980's song, "Freeze-Frame" by The J. Geils Band? A New Year, a new Untitled Letter issued by the Food and Drug…
Arnall Golden Gregory LLP | USA | 26 Jan 2022
Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices
Bob Dylan sang, "Tell Me, I've Got to Know." In January 2022, the Food and Drug Administration said the same to the medical device industry when it…
Arnall Golden Gregory LLP | USA | 24 Jan 2022
You Cannot Do It Any Way You Want It: FDA Issues an Untitled Letter for an Incomplete Journey Forward
Late last year, the Food and Drug Administration's Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful…
Arnall Golden Gregory LLP | USA | 10 Jan 2020
Private Wealth Newsletter - Three Reasons to Revisit Your Estate Plan in 2020
The current estate planning environment, with low interest rates and high estate, gift, and generation-skipping transfer tax exemptions, provides…
Arnall Golden Gregory LLP | USA | 8 Jan 2020
Public Hearing on Proposed Georgia Telemedicine License Regulations Scheduled for January 9, 2020
On December 9, 2019, the Georgia Composite Medical Board (the "Board") proposed rules that set forth the State's requirements for telemedicine…
Arnall Golden Gregory LLP | USA | 8 Jan 2020
Medicare Establishes Criteria to Allow Hospices to Accept Prescription Orders from Physician Assistants
Exactly one year after the Bipartisan Budget Act of 2018 redefined the statutory definition of "attending physician" to allow physician assistants…
Arnall Golden Gregory LLP | USA | 18 Dec 2019
“A Perfect Storm”: OPDP Sends Warning Letter Regarding Print Advertisement for Drug to Treat Opioid Use Disorder—Failure to Disclose Serious Risks, Including Potential for Fatal Overdose
On December 2, 2019, the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug…
Arnall Golden Gregory LLP | USA | 18 Dec 2019
Is Your Cosmetic Product Really Natural? Congress Pushes for Legislation to Define the Term “Natural” for Cosmetics
The use of the term "natural" on the labeling of FDA-regulated products has been the source of many lawsuits in recent years, and even the subject of…
