On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more
In this issue:
- Where did these cases come from?
- What are these cases about?
- Who is driving these cases?
- What are the Plaintiffs suing for?
- Who is a likely target?
- How can...more
On Feb. 25, 2015, nearly two years after argument, the South Carolina Supreme Court directed entry of a $136 million judgment against Janssen Pharmaceuticals Inc. These civil penalties stemmed from a suit brought by the...more
On March 27, 2015, FDA plans to hold a public meeting entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. The meeting was announced in a Federal Register Notice posted...more
An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more
Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more
On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more
In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more
Your company has created and developed a new, innovative product. You’ve tested your product, you’ve adopted a new trademark, and you’re ready to begin manufacturing. The remaining steps of preparing your product for sale,...more
FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity -
The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more
As we’ve explored in past posts, Congress is currently considering a bill that aims to harmonize the patchwork of state efforts at regulating GMO labeling by placing such regulation firmly within FDA’s jurisdiction. Dubbed...more
In This Issue:
- FDA Releases Menu Labeling Rule
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Upcoming Congressional Hearings
- Excerpt from FDA...more
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
- Advocates of GMO labeling vow to continue fight even after electoral...more
NAD Sniffs at Odor Protection Claims -
Concerned that a 48 hour antiperspirant/deodorant constitutes an overstated claim of “100% odor protection,” the National Advertising Division recommended...more
We try to avoid puns in this blog but sometimes, well, we just can’t help it.
The makers of “Rockhard Weekend,” a male sex enhancement pill, have successfully sidestepped a claim that they violated federal drug...more
In This Issue:
- Supreme Court Holds Company Can Sue Competitor For Unfair Competition Even If It Complies With FDA Labeling Regulations:
In an 8-0 decision announced on June 12, 2014, the Supreme Court held...more
Information is power, and as of this month, there’s a new power source of information about drug effects.
openFDA.gov is an initiative of the U.S. Food and Drug Administration to expand access to and use of reports of...more
As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more
The typical suit alleges that consumers are misled because a product labeled as “all natural” in fact contains one or more ingredients that are not natural.
A plaintiff who purchased the product can file suit on behalf...more
In Morgan v. Wallaby Yogurt Co., Inc., the U.S. District Court for the Northern District of California denied defendant’s motion to dismiss a class action complaint alleging violations of the UCL, FAL, and CLRA for...more
Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label...more
On March 3, 2014, the Food & Drug Administration (FDA) published a Notice of Proposed Rulemaking (NPRM) that, if and when finalized, would make important changes to the labeling of all foods subject to FDA’s primary labeling...more
An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more
An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more
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