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Warning Letters

AGG Food and Drug Newsletter - October 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

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

by Arnall Golden Gregory LLP on

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

EU & Competition Law Update – October 2017

by Bryan Cave on

When is a private company considered a public body and subject to the EU procurement rules? A recent European Court of Justice (“ECJ”) case has thrown up a novel legal issue which will be of interest to all public...more

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

by Arnall Golden Gregory LLP on

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

FDA Scolds Company Claiming to Bake with Love

by Faegre Baker Daniels on

Where’s the love? Apparently, not at the FDA. On September 22 the FDA issued Warning Letter CMS# 532236 to Nashoba Brook Bakery, of Concord, Mass. Among several infractions cited in the letter was one for the misbranding...more

EU Retail News - September 2017

by Bryan Cave on

UK Competition Authority Warns Creative Sector About Price Fixing and Information Sharing - On 12th September 2017 the UK Competition Authority,the Competition and Markets Authority ("CMA") sent an open letter to...more

These Flakes Can’t Fake it – FDA Says They’re Not Medical Foods

by Arnall Golden Gregory LLP on

FDA recently issued a warning letter to a medical food manufacturer for several violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The violations were discovered during FDA’s inspection of the facility. FDA said...more

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

AGG Food and Drug Newsletter - September 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

Recent Warning Letters from FDA about Medical Devices: Investigational Device Exemptions and Lack of Marketing Authorization are...

by Arnall Golden Gregory LLP on

Over the past several months, the Food and Drug Administration (FDA) has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device...more

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

by Arnall Golden Gregory LLP on

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

by Arnall Golden Gregory LLP on

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

UK Competition Authority warns Creative Sector about Price Fixing and Information Sharing

by Bryan Cave on

On 12th September 2017 the UK competition authority, the Competition and Markets Authority (“CMA”) sent an open letter to businesses in the creative industries sector warning them about price fixing and information sharing,...more

Dear Influencers: It’s the FTC, Again – FTC Issues 21 Follow-up Warning Letters

by Dorsey & Whitney LLP on

Back in the Spring, we posted about a set of 90 warning letters the FTC sent to influencers and brands about the disclosure of material connections on Instagram. While you may have spent your summer trying to unplug, the FTC...more

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

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