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
Please join AGG Food & Drug practice team leader Alan G. Minsk and AGG Brands and Advertising attorneys Anuj Desai and Matthew V. Wilson for a complimentary webinar discussing current legal and regulatory trends for...more
8/2/2022
/ Advertising ,
Best Practices ,
Continuing Legal Education ,
Endorsements ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Influencers ,
Marketing ,
Risk Management ,
Social Media ,
Sponsorship Agreements ,
Talent Management ,
Webinars
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
In September 2014, AGG prepared a Bulletin on the Food and Drug Administration’s Breakthrough Therapy Designation (BTD) program, referencing The Doors’ “Break On Through to the Other Side.” Time for Part 2. FDA issued a draft...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
Channeling Led Zeppelin’s “In Through The Out Door,” in May 2022, the Food and Drug Administration issued a guidance for industry entitled, “Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity...more
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
In 1964, Sam Cooke sang “A Change is Gonna Come.” In March 2022, the Advanced Medical Technology (AdvaMed) said the same when it announced revisions to its Code of Ethics on Interactions with Health Care Professionals (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
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
Channeling Lynyrd Skynyrd’s 1977 classic song, “That Smell,” on January 1, 2022, California Senate Bill 312 (SB 312), now known as the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (“CFFIRKA”), went into...more
In 1969, The Beatles told Jo Jo and Loretta to “get back to where you once belonged.” In 2021, we could view a documentary series by the same name about the recording sessions behind the classic Let It Be album. FDA officials...more
The Food and Drug Administration recently issued a Warning Letter to a medical device manufacturer for making significant changes to its 510(k)-cleared products for uses outside the scope of the 510(k) clearance, among other...more
In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more
3/15/2022
/ Comment Period ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
ISOs ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform
The Food and Drug Administration let sponsors and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more
3/2/2022
/ Biotechnology ,
CARES Act ,
Draft Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
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
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; little things make big things bigger”), the Food and Drug Administration’s...more
2/22/2022
/ Drug Distribution ,
Enforcement Actions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Listing Standards ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Standards ,
Supply Chain ,
Warning Letters
Please join AGG Food & Drug attorneys Alan G. Minsk and Laura S. Dona for a complimentary webinar reviewing past FDA letters issued to pharmaceutical and medical device companies for unlawful promotion in 2021 and where FDA...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
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
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 Administration’s Office of Prescription Drug Promotion to a prescription drug company....more
1/31/2022
/ Advertising ,
Enforcement Actions ,
False Advertising ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Marketing ,
Misleading Statements ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sales Promotions ,
Social Media
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 issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more
1/26/2022
/ Business Disruption ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Notification Requirements ,
Pharmaceutical Industry ,
Public Health ,
Public Health Emergency ,
Regulatory Requirements ,
Supply Chain
Late last year, the Food and Drug Administration’s Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product....more
1/25/2022
/ Advertising ,
Biologics ,
Direct to Consumer Sales ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
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
12/28/2021
/ Anti-Kickback Statute ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Healthcare ,
Infectious Diseases ,
Life Sciences ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Telehealth ,
User Fees