The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
3/26/2025
/ Compliance ,
Draft Guidance ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Public Health ,
Regulatory Requirements ,
Risk Management ,
Warning Letters
“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
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
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 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
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
To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more
9/22/2015
/ Administrative Procedure Act ,
Amarin ,
Declaratory Relief ,
Due Process ,
Enforcement Actions ,
Ex Post Facto Clause ,
Fair Notice ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fifth Amendment ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Injunctive Relief ,
Misbranding ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry