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
From the 1978 52nd Street album, Billy Joel sings, “Honesty is such a lonely word, everyone is so untrue; honesty is hardly ever heard, and mostly what I need from you.” While we don’t want to start out this Bulletin on such...more
The authors doubt the Food and Drug Administration was humming the Goo Goo Dolls 1995 hit, “Name,” when it drafted its letter, dated October 18, 2021, to manufacturers of in vitro diagnostics to remind them that the agency...more
Rule Number One: If a facility is regulated by the Food and Drug Administration, the agency may inspect it (although there are some boundaries, not discussed here)....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
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 1970, Gordon Lightfoot released the classic song “If You Could Read My Mind,” where he sings, “If you could read my mind, love, what a tale your thoughts could tell.” Fifty-one years later, the Food and Drug Administration...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
7/26/2021
/ Cybersecurity ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Home Health Care ,
Life Sciences ,
Medical Devices ,
Medicare ,
OPDP ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
State Privacy Laws
Channeling Johnny Nash and the 1972 classic song, “I Can See Clearly Now,” on July 7, 2021, the Food and Drug Administration issued its final guidance titled, “Unique Device Identification System: Form and Content of the...more
In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and Genevieve M. Razick, an attorney in our Healthcare and Food & Drug practices, along with Leah D. Braukman, an attorney in our Corporate & Finance practice,...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
The Food and Drug Administration recently approved a drug product to treat Alzheimer’s disease under the accelerated approval pathway, putting the spotlight back on what exactly is “accelerated approval?” This Bulletin will...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
On April 27, 2021, the Food and Drug Administration issued its first Notice of Noncompliance to a pharmaceutical company for failure to submit required information to the ClinicalTrials.gov databank operated by the National...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
Channeling The Who’s Tommy Soundtrack and the classic song “See Me, Feel Me,” the Food and Drug Administration issued a guidance document, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring...more
In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG's Data Privacy practice, Kevin L. Coy, discuss U.S. and international privacy and data security law issues life sciences companies may...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
3/29/2021
/ Advertising ,
Endorsements ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Marketing ,
Medical Devices ,
Misleading Impressions ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Warning Letters ,
Websites
In keeping with family tradition, another Kardashian made headlines again in our food and drug world for the wrong reasons. And FDA’s Office of Prescription Drug Promotion (OPDP) was not likely amused to issue its third...more
Well, that was fast. Fresh off issuing its first Warning Letter of 2021,1 the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) struck again. OPDP sent the Warning Letter to the drug company a day...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
2/25/2021
/ Advertising ,
Anti-Kickback Statute ,
Biologics ,
Biotechnology ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Investigations ,
Life Sciences ,
Marketing ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Warning Letters
In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and team member, Genevieve M. Razick give an overview of FDA’s Office of Prescription Drug Promotion's (OPDP) enforcement of unlawful advertising in 2020.
Each...more
New Year. Same Types of Issues. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued its first Warning Letter of 2021, and it identified many of the same types of unlawful promotional...more
Good riddance to 2020 for so many reasons. But, as the AGG Year in Review of the Food and Drug Administration’s enforcement of prescription drug advertising and promotion has become an annual ritual, let’s take a quick peek...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