As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, less attention has been given to the new administration’s regulatory impact abroad....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
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 (arguably, his best song), came to mind when we saw that the Food and Drug Administration issued a draft guidance, “Formal Dispute Resolution and Administrative...more
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
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 In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more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Draft Guidance ,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
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug Practice....more
From his 1986 “Back in the High Life” album, Steve Winwood sings, “It’s a fine line, a very fine line – split decision.” In fact, that’s what many medical device companies will face as they review the Food and Drug...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
1/26/2018
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
CGMP ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Drug Pricing ,
False Claims Act (FCA) ,
FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Human Resources Professionals ,
OCR ,
PHRMA
In the 1984 movie, “This is Spinal Tap,” one of the characters utters, “It’s such a fine line between clever and stupid.” This classic line comes to mind as we review an issue involving First Databank Inc.’s (FDB’s) decision...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
In the span of three weeks, the Food and Drug Administration issued Warning Letters to two dietary supplement companies, in part, for relying, to their detriment, on quality agreements. We discussed another similar Warning...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in...more
Some of us remember the television commercial and poster, created by the then-audio cassette company, Memorex, asking “is it live, or is it Memorex?” Forty years later, the Food and Drug Administration could paraphrase the...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...more
To paraphrase, admittedly horribly, the Cole Porter classic, “I’ve Got You Under My Skin,” a number of cosmetic companies got under the Food and Drug Administration’s (FDA) skin in 2015 for making unapproved new drug claims....more
In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...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
In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more