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AGG Food and Drug Newsletter - April 2018

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

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating...more

AGG Food and Drug Newsletter - March 2018

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

Don’t You Forget About Me: FDA Kicks off 2018 with Letters on Promotional Activities

FDA’s Office of Prescription Drug Promotion (OPDP) issued only five letters in 2017 (compared to eleven in 2016 and nine in 2015). This relatively slow year left some prescription drug manufacturers wondering if, to quote the...more

AGG Food and Drug Newsletter - February 2018

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

Urgent, Urgent, Urgent … Emergency: FDA Advises Companies to Issue Appropriate Product Recall Warnings

Channeling the rock band Foreigner and its 1981 hit, “Urgent” (or the Beatles’ “Get Back” single), the Food and Drug Administration issued a draft guidance in January 2018, cautioning industry to properly warn the public...more

2/22/2018  /  Draft Guidance , FDA , HHS , OIG , Popular , Product Recalls

AGG Food and Drug Newsletter - January 2018

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

A Fine Line Between Prescription and Under a Doctor’s Supervision: The Case of Medical Foods and First Databank’s Classification

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

1/24/2018  /  FD&C Act , FDA , Medical Foods

Get by with a Little Help from My Friends (Maybe Not): FDA Reiterates Reliance on Others Doesn’t Ensure Regulatory Compliance

Here we go again. The Food and Drug Administration issued a Warning Letter on December 13, 2017, to a Korean pharmaceutical company for non-compliance with current Good Manufacturing Practice requirements. What caught our eye...more

AGG Food and Drug Newsletter - November 2017

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 Issues Guidance on Submitting 510(k)s for Changes to Existing Devices

On October 25, 2017, the Food and Drug Administration (FDA) issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would...more

AGG Food and Drug Newsletter - October 2017

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

You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements

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

I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect

Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back...more

AGG Food and Drug Newsletter - September 2017

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

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

AGG Food and Drug Newsletter - August 2017

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

Sign, Sign, Everywhere A Sign: Don’t Overlook What FDA Says and Writes

In the 1971 song, “Signs,” the Canadian rock band, Five Man Electrical Band sang, “Sign, Sign, Everywhere a Sign … Can’t You Read the Sign?” The lyric resonates with us periodically as we discuss with a client a response from...more

AGG Food and Drug Newsletter - June 2017

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

6/19/2017  /  FDA , HHS , HIPAA , OCR , PHI , Prescription Drugs , Warning Letters

Spelling Counts (Among Other Things): FDA Issues Warning Letters for Mistakes in Drug Listing

Recently, the Food and Drug Administration issued two Warning Letters to pharmaceutical companies for failing to fulfill product listing obligations for what appear to be oversights. In the first letter issued at the end of...more

AGG Food and Drug Newsletter - May 2017

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

Money for Nothin': FDA's PDUFA Fee Waivers and Exemptions

Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more

Things That Make You Go Hmmm, Part II: Drug Company Plays Games With FDA To Delay Facility Inspection

More than ten years ago, I wrote an article about a company action that invoked a memory of my then-3-year old son’s playful “The Thinker” pose. (I continue to have this picture hanging in my office now.) He would frequently...more

Doctor, Doctor, Give Me the News, I’ve Got a Bad Case of Medical App Blues: Mobile Medical Application Developers Settle with New...

The New York Office of the Attorney General recently announced settlements with developers of three mobile health applications due to misleading claims and deficient privacy practices. As a result of these settlements, the...more

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