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Warning Letters

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

Solution to One Problem Brings Two More

by Faegre Baker Daniels on

An August 2 FDA warning letter provides a reminder that solving one problem can create a new problem—or more. The letter to Coleman Peanut Co., in Petersburg VA, recites that the company uses a cat “as the firm’s pest...more

Electronic Drug Product Listing Errors Can Result in FDA Warning Letter

by Morgan Lewis on

FDA Warning Letters focus on inaccurate drug product listings. Over the last year, the US Food and Drug Administration (FDA or Agency) has increased its enforcement efforts concerning drug product listing requirements,...more

Pfizer Gets Second CRL On Proposed Epoetin Alfa Biosimilar

by Goodwin on

According to a Pfizer press release, the FDA has issued a second Complete Response Letter (CRL) to Pfizer in connection with the company’s aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha)....more

AGG Food and Drug Newsletter - June 2017

by Arnall Golden Gregory LLP on

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

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

by Arnall Golden Gregory LLP on

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

Ultrasonic Cross-Device Tracking: A Consumer Management Tool with FTC Warnings

A consumer’s television or computer may be emitting silent signals that her smartphone can hear, recognize and answer back, but the consumer can’t sense them at all. These signals are telling retailers about their customer’s...more

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

by Arnall Golden Gregory LLP on

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

The FTC Gets Specific on Influencer Material Connection Disclosures

by Dorsey & Whitney LLP on

A few weeks ago we blogged about the FTC’s warning letter writing campaign to brands and influencers about disclosure of material connections on Instagram. At that time, the FTC had only released sample letters – one for one...more

Dear Influencers: #FullDisclosure we use Instagram too. Love, The FTC – Warning letters provide guidance to influencers,...

by Dorsey & Whitney LLP on

Instagram is now home to more than 600 million users, including many popular brands, celebrities, online influencers, famous dogs, regular people and regular dogs (full disclosure this regular dog is mine). As its popularity...more

FDA Is Cold As Ice As It Steps Up Foreign Inspection Enforcement

by Arnall Golden Gregory LLP on

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released fourteen Warning Letters. Of these, 100% involved manufacturing facilities...more

“Final warning” on Air pollution from the European Commission

by Latham & Watkins LLP on

On 15 February 2017, the European Commission (the Commission) sent final warnings (a Reasoned Opinion) to France, Germany, Italy, Spain and the United Kingdom for failing to comply with the air pollution limits for nitrogen...more

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

by Hogan Lovells on

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

Anyone Can Enter Into a Quality Agreement, It's the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight

Many of us remember the classic comedy bit on the Seinfeld television show where Jerry was unable to secure the rental car for which he had made a reservation. He tells the agent: See, you know how to ‘take’ the...more

Happy Holidays from FDA: The Agency Issues Four Enforcement Letters for Unlawful Promotion

by Arnall Golden Gregory LLP on

The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...more

Words Matter: Product Claims Can Trigger Regulatory Application And Corrective Action

by Cozen O'Connor on

Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance. This is certainly true in the area of product claims or statements. ...more

Mortgage Lenders Receive Wake Up Call from CFPB

by Reed Smith on

Last week, the CFPB issued a warning letter to 44 mortgage lenders and brokers concerning possible violations related to their collection and reporting of mortgage data under the Home Mortgage Disclosure Act (HMDA) and...more

What’s in a Name? Looming Food Identity Issues…

by Davis Wright Tremaine LLP on

Chase Purdy at Quartz recently published an article with the following headline: “To lure people put off by the freakiness of lab-made meat, this is what the industry wants to call it.” It got me thinking about the importance...more

AGG Food and Drug Newsletter - October 2016

by Arnall Golden Gregory LLP on

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

What a Difference a Claim Can Make: FDA Issues a Warning Letter for Unlawful Medical Device Promotion

by Arnall Golden Gregory LLP on

Much has been written, including by us, about the Food and Drug Administration’s enforcement approach (or lack thereof) concerning off-label promotion. However, FDA has not curled itself up into a ball, abdicating its...more

Don’t Come Around Here No More: A Drug Company Receives a Warning Letter for Limiting Inspection

by Arnall Golden Gregory LLP on

In the “what were they thinking department,” a drug company located outside of the United States recently received a Warning Letter for limiting and refusing an FDA inspection. In addition, the agency placed the company on an...more

The Digital Download - Alston & Bird’s Privacy & Data Security Newsletter – August 2016

by Alston & Bird on

General Data Protection Regulation (GDPR) Published, Commencing Two-Year Countdown to Application. One of the most important EU legislative initiatives in recent years, and a landmark in privacy regulation worldwide, the GDPR...more

You Wear It Well (or Do You?): FDA Objects To These Skincare Companies’ Unapproved New Drug Claims

by Arnall Golden Gregory LLP on

In the 1972 hit, “You Wear it Well,” Rod Stewart sang about a woman and offered the classic line, “Madame Onassis got nothing on you.” The tune came to mind when reading four Warning Letters issued by the Food and Drug...more

FTC Sends Warning Letters to Companies Making Zika Virus-Protection Claims

by Reed Smith on

Last Friday, the Federal Trade Commission (“FTC”) sent warning letters to ten online marketers that were making Zika virus-protection claims. The Center for Disease Control believes that the Zika virus is spread primarily...more

Avoiding the Road to Ruin in Your Road To Rio Marketing Blitz

by Dorsey & Whitney LLP on

Late last month, the United States Olympic Committee (the “USOC”) sent a few not so nice warning letters to brands that sponsor athletes, but chose not to pay the “golden” price of becoming an “official” sponsor of the games....more

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