The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more
Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more
When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
This (bad) pun of the 1974 Carly Simon song, “Haven’t Got Time for the Pain,” came to mind when we read the Food and Drug Administration’s Office of Prescription Drug Promotion’s (“OPDP”) first Notice of Violation of 2025....more
Peter Murphy’s 1989 single, “Cuts You Up,” came to mind when we read FDA’s Office of Prescription Drug Promotion’s (“OPDP”) latest Notice of Violation....more
11/20/2024
/ Advertising ,
Celebrity Endorsements ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Marketing ,
Misleading Statements ,
Notice of Violation ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Warning Letters
In 1984, the international rock band, The Scorpions, released the song, “Rock You Like a Hurricane.” Forty years later, the Food and Drug Administration’s Office of Prescription Drug Promotion rocked a pharmaceutical company...more
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
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
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
“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
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
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
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
In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more
2/25/2022
/ Advertising ,
Enforcement Actions ,
FDA Approval ,
FDA Warning Letters ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational New Drug Application (IND) ,
Life Sciences ,
Marketing ,
Misleading Statements ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs
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
2/1/2022
/ Advertising ,
Biden v Missouri ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Workers ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
National Federation of Independent Business v Department of Labor and OSHA ,
OPDP ,
Opioid ,
OSHA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain ,
Vaccinations