Much like how Ray Charles lamented in 1967, the pharmaceutical industry is saying, “Here we go again, she’s back in town again,” as the Food and Drug Administration issued its second Notice of Violation in a month. Last week,...more
In 1987, the influential garage rock band, The Replacements, led by Paul Westerberg, sang, “I can’t hardly wait.” Years later, the Food and Drug Administration issued a Notice of Violation — the second this year — to a...more
Thin Lizzy famously declared in their 1976 hit, “The Boys are Back in Town.” The same is true almost 50 years later, as the U.S. Food and Drug Administration has announced its plan to phase out its general enforcement...more
In 1973, Sir Elton John sang, “Harmony and me, we’re pretty good company,” on his classic album, Goodbye Yellow Brick Road. More than 50 years later, the Food and Drug Administration issued a Final Rule to amend the medical...more
Better Than Ezra’s early 1990s single, “This Time of Year,” came to mind when we saw the Food and Drug Administration’s Office of Prescription Drug Promotion issue its first Untitled Letter (also known as a Notice of...more
A recent development with the Food and Drug Administration made us think of a song lyric from Florida native and Rock and Roll Hall of Famer, Tom Petty, “What lies ahead, [we] have no way of knowing.” As a kick-off to 2024,...more
When we think of compounding, which is the process of combining, mixing, or altering ingredients to create a medication specific to the needs of an individual patient, we think of the Cars’ 1978 classic, “It’s All Mixed Up.”...more
We remember the late Jimmy Buffett who sang in his 1977 classic, “Changes in latitudes, changes in attitudes; Nothing remains quite the same.” Demonstrating a change in attitude, in September, the Food and Drug Administration...more
FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more
9/6/2023
/ Artificial Intelligence ,
Continuing Legal Education ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Webinars
In his 1973 song, “Nostradamus,” singer-songwriter Al Stewart sang, “I am the eyes of Nostradamus, all your ways are known to me.” So, we started thinking, what would Mr. Stewart think of FDA’s Office of Prescription Drug...more
We pay tribute in this Bulletin to the late Robbie Robertson of The Band, who penned the 1968 classic, “The Weight,” and the harmonic lyric, “You put the load right on me.” The Food and Drug Administration’s Office of...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
8/18/2023
/ Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
NAD ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Warning Letters
Todd Rundgren’s 1978 classic, “Can We Still Be Friends?” (arguably, his best song), came to mind when we saw that the Food and Drug Administration issued a draft guidance, “Formal Dispute Resolution and Administrative...more
“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more
FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more
Last month, the Food and Drug Administration’s Office of Orphan Products Development (“OOPD”) found that one prescription drug company was able to, essentially, breach another’s orphan drug exclusivity (and have its new drug...more
Many of us remember the television commercial where an older woman falls and cries out, “Help! I’ve fallen and I can’t get up.” This image and quote came to our mind when FDA recently issued a Warning Letter to a medical...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Channeling Joe Jackson’s 1982 catchy hit, “Steppin’ Out,” the National Advertising Division (“NAD”) of the BBB National Programs recently released a decision regarding a prescription drug advertisement, resulting in the...more
Recently, the Food and Drug Administration published a Notification to clarify its policy about orphan drug exclusivity. The agency issued the announcement because the U.S. Court of Appeals for the 11th Circuit found that FDA...more
Recently, the Food and Drug Administration published a revision to its final guidance document titled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” originally issued...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more
6/23/2022
/ Advertising ,
Enforcement Actions ,
FDA Warning Letters ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Marketing ,
Misleading Statements ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs
Who doesn’t remember Hall and Oates’ 1984 hit, “Out of Touch?” Perhaps, reviewers in the Food and Drug Administration’s Office of Prescription Drug Promotion were humming this song when it recently issued an Untitled Letter...more
4/18/2022
/ Advertising ,
Direct to Consumer Sales ,
Enforcement Actions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Marketing ,
Misleading Impressions ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Television Commercials
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
3/28/2022
/ 510(k) RTA ,
Cosmetics ,
FDA Warning Letters ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational New Drug Application (IND) ,
Life Sciences ,
OPDP ,
Personal Care Products ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements