Please join AGG Food & Drug co-chair Alan G. Minsk and Taylor Wessing Life Sciences and Healthcare attorneys Dr. Manja Epping and Irina Rebin for a complimentary webinar exploring the regulatory landscape of clinical trial...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Draft Guidance ,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 (arguably, his best song), came to mind when we saw that the Food and Drug Administration issued a draft guidance, “Formal Dispute Resolution and Administrative...more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
Before Comedy Central, TikTok videos, and other social media inventions, Monty Python entertained us (admittedly, an acquired taste). Many of us remember the classic scene from the 1975 movie Monty Python and the Holy Grail,...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
In 1994, the rock band Bush sang, “breathe in, breathe out,” in one of its biggest hits, “Machinehead.” In 2023, a medical device company tried to promote its 510(k)-cleared treatment hood/hyperbaric chamber device for...more
It’s not clear whether the prescription drug company was channeling Electric Light Orchestra’s 1979 hit or The Animals’ 1966 song, but “Don’t Bring Me Down” was the attitude when the company declined to participate in a case...more
In 1978, Bruce Springsteen sang “Prove It All Night.” Forty-five years later (on April 13, 2023), the Federal Trade Commission (“FTC”), a different Boss, reminded approximately 670 over-the-counter drug, homeopathic product,...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
Channeling Men Without Hats’ 1982 catchy (not classic) hit, “Safety Dance,” FDA told industry in a recently issued guidance that medical device companies could submit marketing applications for cyber devices if they want to...more
Recently, a medical device company received a Warning Letter from FDA for a number of quality-related deficiencies, including issues with Medical Device Reporting (“MDR”), the promptness (or lack thereof) of handling and...more
In this episode, Alan G. Minsk, AGG Food & Drug team leader, and Anuj Desai, AGG Intellectual Property partner and head of Trademarks, discuss recent developments that remind our audience in the food and drug space that FDA...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
“Tell Me Lies, Tell Me Sweet Little Lies,” from the 1987 Fleetwood Mac song, “Little Lies,” came to mind in the last few days. One, because of the unfortunate passing of Christine McVie, the song’s co-writer. Two, because one...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
Please join AGG litigators David J. Marmins and Morgan E. M. Harrison and AGG Food & Drug practice team leader Alan G. Minsk for a complimentary webinar addressing the recent spate of litigation against cosmetic companies...more
In 1982, Chris de Burgh (of “Lady in Red” fame) sang, “Don’t pay the ferryman, don’t even fix a price until he gets you to the other side,” where the narrator warns the passenger not to pay the ferryman (because a storm...more
In a colorful nod to one of Georgia’s most famous and respected musical bands, R.E.M., and its 1988 hit, “Orange Crush” (from the album Green — coincidence?), in July 2022, the Food and Drug Administration issued a guidance...more