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
Congress, the Food and Drug Administration, the pharmaceutical industry, and the general public are concerned about ensuring the safety and security of the pharmaceutical distribution supply chain. The Drug Supply Chain...more
The Food and Drug Administration announced recently that it intends to re-evaluate its policies on opioid medications, designed “at reversing the epidemic, while still providing patients in pain access to effective relief.”...more
On January 4, 2016, the Food and Drug Administration (FDA) released a draft guidance intended to clarify the Unique Device Identifier (UDI) labeling requirements for certain medical devices packaged together as “convenience...more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
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 this Bulletin, we highlight some of these findings, which provide a glimpse into FDA’s priority concerns and should help companies proactively and properly plan for their next inspections. To paraphrase from the rock band...more
The pharmaceutical industry has recently felt empowered and emboldened by recent litigation that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e., off-label, so long as the...more
Taking a page (or lyric) from Todd Rundgren’s 1978 song, “Can We Still Be Friends,” it looks like the government, namely, the Food and Drug Administration and Department of Justice, and Pacira Pharmaceuticals, are looking to...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
The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. 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
Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...more
8/27/2015
/ 510(k) RTA ,
Bifurcation ,
Commercial Speech ,
Data Security ,
Evidence ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Free Speech ,
Litigation Hold ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Privacy Policy ,
Sanctions
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
The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more