Labeling

News & Analysis as of

Brewers’ Voluntary Disclosure Initiative Introduced

As the food and beverage industry trends toward products and practices that promote consumer choice and transparency, the Beer Institute has recently announced a new Voluntary Disclosure Initiative (the “Initiative”), which...more

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

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

Overlapping Labels Can Lead to Liability

Multiple regulatory agencies worldwide exercise jurisdiction over how hazards associated with chemicals in the workplace are communicated to employees and others. This creates a complex web of requirements and...more

Environmental Notes - August 2016

Time to Pay More: EPA Increases Maximum Civil Penalties - Remember the days when the maximum civil penalty EPA could assess for a violation of environmental law was $25,000 per day? Those days disappeared 26 years ago...more

First-Ever Federal Labeling Requirements for Bioengineered Foods Signed Into Law

On July 29, President Obama signed into law a bill establishing first-ever federal requirements for the labeling of food containing genetically engineered ingredients. The bill, known as S.764, directs the U.S. Department of...more

PhRMA and BIO Take Off-Label Communication Into Their Own Hands with New Guidelines

Industry for years has sought clarity on off-label communications. Numerous meetings on the topic have taken place between the U.S. Food and Drug Administration (FDA) and industry, citizen petitions have been filed,...more

EPA Issues Final Rule Implementing Formaldehyde Emission Standards

Final rule seeks to reduce exposure to formaldehyde vapors by establishing emission standards and labeling requirements for certain wood products. Six years after the passage of the Formaldehyde Emission Standards for...more

GHS Update: Government of Canada introduces new regulations for protection for workers handling hazardous materials

The Government of Canada has announced that new Occupational Health and Safety regulations under the Canada Labour Code, which are intended to better protect federally regulated workers who use, handle and store hazardous...more

FDA Offers Draft Guidance for Generic Drug Label Updates

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

European Parliament Calls for Extended Application of Country of Origin Labeling in the EU Just When the WTO Dispute on the United...

On May 12, 2016, the European Parliament renewed its call for mandatory country-of-origin labeling (“COOL”) for meat and dairy products not currently subject to such marking rules. The reasoning behind requiring additional...more

BREAKING NEWS: FDA Denies Citizen Petitions Regarding Biosimilar Labeling

FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations...more

Big Brewers Hopping on the Transparency Train

Transparency is a hot topic in the food world these days. The U.S. Food and Drug Administration (FDA) recently finalized an update to the nutrition facts panel for packaged foods. The U.S. Senate last week advanced a bill...more

FDA Draft Guidance on Updating Generic Labels When RLD Withdrawn

On Friday, the FDA issued a draft guidance document intended to provide ANDA holders with information about how and when to propose any necessary labeling updates to their drugs when the reference-listed drug (RLD) upon which...more

FDA's Draft Guidance to Help Manufacturers in Labeling Biosimilars

The passage of the Biologics Price Competition and Innovation Act (BPCIA) in 2010 paved the way for the introduction of biosimilars in the United States. Biosimilars are large-molecule drugs that are highly similar, but not...more

FDA Regulatory and Compliance Monthly Recap – June 2016

FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions - The draft guidance will amend the FDA’s 20-year-old policy for categorizing devices...more

FDA Issues Final Rule on Use of Symbols in Labeling

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

FTC Civil Penalties on the Rise—Inflation Adjustments Increase Civil Penalty Amounts

For the first time since 2009, the potential civil penalties for violating an administrative consent order under Section 5(b) of the FTC Act is going up. The maximum civil penalty the Federal Trade Commission (FTC) can now...more

Picture of Health: FDA Rule Allows Symbols to Replace Text on Device Labels

In June 2016, the U.S. Food and Drug Administration (FDA) issued its final rule explicitly allowing the use of approved symbols, without accompanying text, on medical device and certain biological product labeling. The FDA...more

FDA Withdraws Previous Notice Seeking Comments on Proposed Biologic Naming Guidance

Earlier this month we reported that FDA had published a notice in the Federal Register soliciting comments on a proposed biologic naming guidance whereby applicants for biologic products would submit up to 10 proposed...more

FDA Issues Interim Response to PhRMA/BIO Joint Citizen Petition on Biosimilar Labeling

As we previously reported, late last year the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) trade associations jointly submitted a Citizen Petition asking the FDA...more

A Symbolic Victory? FDA's Final Rule On Stand-Alone Symbols In Medical Device Labeling Raises Important Litigation Risk Questions

FDA this week released a final rule that will undoubtedly raise new litigation questions for medical device manufacturers in the context of product liability claims. The final rule, for the first time, permits medical device...more

Calif. Asks Innovator Drug Brands to Do the Impossible

Eight years ago, in Conte v. Wyeth, the California Court of Appeals shocked brand prescription drug manufacturers when it held that they could be liable for injuries caused by generic versions of their medications — an...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

Update on Naming Biosimilars

In August 2015, FDA released a long-awaited draft guidance for the nonproprietary names of biologics and biosimilars. The draft guidance recommends that nonproprietary names for biologic products should consist of the “core”...more

258 Results
|
View per page
Page: of 11
JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×