News & Analysis as of

Labeling The United States Food and Drug Administration

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

Working Together: FDA Releases Final Guidance on Interoperability

by Hogan Lovells on

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

As Medical Food Industry Grows, So May FDA Scrutiny

by Baker Donelson on

On September 1, the United States Food and Drug Administration (FDA) issued a Warning Letter to ND Labs, Inc. of Lynbrook, New York, regarding its LPS Cherry, Liquid Fiber Flow, and Nana Flakes 'medical food' products. The...more

FDA Issues Final Guidance For Medical Device Exchange of Patient Information

The Food and Drug Administration (FDA) issued guidance yesterday (September 6, 2017) entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices,” which is intended to “assist...more

Blog: Off-Label Use Gets Congressional Hearing

by Cooley LLP on

Today, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug...more

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

by Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

Picking Up the Post-Preemption Pieces

by Reed Smith on

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case. Applying a ruling on in limines from one case to another can be a dicey proposition...more

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

by Morgan Lewis on

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

FDA-Approved Labeling Does Not Equal Medical Standard Of Care

by Reed Smith on

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that...more

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

by Ropes & Gray LLP on

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

by Pepper Hamilton LLP on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

FDA Issues Draft Guidance on Communications That Are Consistent with FDA-Required Labeling

by McDermott Will & Emery on

This On the Subject reviews the US Food and Drug Administration’s recently released draft guidance on promotional materials and communications that are consistent with FDA-required labeling. The guidance provides a...more

FDA Response to Biosimilar Naming Petitionx Just Issued

by Goodwin on

On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their...more

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

by Hogan Lovells on

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

by King & Spalding on

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

FDA Makes Public the Scientific Data Evaluated and Provides Draft Guidance Regarding the Inclusion of Certain Fibers in the...

As previously reported, in May 2016, the Food and Drug Administration (FDA or agency) published new final regulations on Nutrition and Supplement Facts labeling. As part of the final rules, FDA defined “dietary fiber,” in...more

FDA takes a half-step toward acknowledging manufacturers' right to disseminate truthful, non-misleading off-label information

by DLA Piper on

The FDA has issued significant new Draft Guidance on January 17, 2017 that touches on the hot-button issues surrounding manufacturer dissemination of off-label information about approved drugs and medical devices, titled...more

FDA Releases Biosimilar Naming Guidance

by Goodwin on

FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should...more

FDA: The Powdered Gloves Come Off

by Stinson Leonard Street on

In a rare move, the Food and Drug Administration (FDA) announced on Friday that it is banning the following devices after determining that they present an unreasonable and substantial risk of illness or injury that cannot be...more

Anything Worthwhile For Product Liability Defendants In The 21st Century Cures Act?

by Reed Smith on

We blogged about possibly interesting nuggets in the 21st Century Cures Act (“21CCA”) back in February, 2015 – when it was only 400 pages long. In true congressional fashion, it’s now twice as long and loaded up with enough...more

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