News & Analysis as of

Food and Drug Administration (FDA) Defense Strategies

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

Fenwick & West LLP on

In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more

Womble Bond Dickinson

Codifying the Experimental Use Exception? USPTO Seeks Public Input

Womble Bond Dickinson on

The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more

Venable LLP

Mitigating Class Action Exposure: An Excerpt from the Advertising Law Tool Kit

Venable LLP on

When it comes to mitigating the risk of class action lawsuits, the best offense is a good defense. Companies can take many steps to reduce their exposure to class action litigation before it happens, including the tactics...more

Venable LLP

[Event] 10th Advertising Law Symposium - March 21st, Washington, DC

Venable LLP on

It’s that time of year again—Ad Law Symposium is back! Please join us in DC for this highly anticipated event focused on providing you with the information you need to promote your brand with confidence. Combining the...more

DRI

[Event] Drug and Medical Device Seminar - May 20th - 22nd, Washington, DC

DRI on

Join us in Washington D.C. for the Drug and Medical Device industry’s premier event for learning, networking, and advancing the defense of life sciences clients! You’ll hear from heads of litigation from the world’s foremost...more

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more

Holland & Knight LLP

Food and Beverage Labeling Defense Strategies

Holland & Knight LLP on

A trio of recent cases challenging disparate food and beverage labels offers a few common substantive and procedural lessons for companies. First, the back panels – when considered in light of U.S. Food and Drug...more

Oberheiden P.C.

Recent DOJ Consumer Protection Branch Cases Highlight the Branch’s Enforcement Priorities

Oberheiden P.C. on

The U.S. Department of Justice’s (DOJ) Consumer Protection Branch works with other branches and federal law enforcement agencies to investigate and prosecute civil and criminal violations of the nation’s consumer protection...more

Oberheiden P.C.

6 FDA Audit Defense Strategies

Oberheiden P.C. on

An audit by the Food and Drug Administration (FDA) can uncover violations of federal food and drug regulations, as well as the Food, Drug, and Cosmetic Act (FD&C Act). Those violations can lead to administrative, civil, or...more

Oberheiden P.C.

Did You Receive an FDA Warning Letter? Here's What to Do Next

Oberheiden P.C. on

What is an FDA Warning Letter? Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

Oberheiden P.C. on

Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

Oberheiden P.C.

FDA Warning Letter Response Strategies (Step-By-Step)

Oberheiden P.C. on

FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more

Oberheiden P.C.

Prescription and Medication Counterfeiting Defense

Oberheiden P.C. on

21 U.S.C. § 331: Selling Counterfeit Drugs - Under Section 331, it is illegal to sell counterfeit drugs in interstate commerce. Because this includes online sales, the “interstate commerce” element is very easy to...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Oberheiden P.C.

The FDA is Investigating Companies that Produce and Sell Poppy Seeds Due to Suspected Contamination

Oberheiden P.C. on

The U.S. Food and Drug Administration (FDA) is investigating companies that produce and sell poppy seeds due to growing concerns over contamination with a controlled substance. In doing so, it is collaborating with the Drug...more

American Conference Institute (ACI)

[Virtual Event] Advanced Legal, Regulatory and Compliance Forum on Over the Counter Drugs - February 26th, 9:00 am - 5:45 pm EST

A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more

Haug Partners LLP

Clarifying the Scope of the Parallel Claim Exception to Federal Regulatory Preemption of Medical Devices

Haug Partners LLP on

Medical device manufacturers who seek to dispose of meritless claims at the initial pleading stage have long relied upon the doctrine of federal regulatory preemption. This doctrine is embodied by 21 U.S.C. § 360k(a), the...more

Butler Snow LLP

Revisiting “Is ‘The Government Said I Could’ A Civil Liability Defense?” During COVID-19

Butler Snow LLP on

Late last year we covered a decision finding a mine operator could not be held liable for unpermitted discharges under the Clean Water Act because it had properly disclosed them to the state permitting authority, which “chose...more

American Conference Institute (ACI)

[Event] Drug and Medical Device Litigation – the Must-Attend Event for the Life Sciences Products Liability Community - December...

Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more

Epiq

New Supreme Court Decision Offers Guidance for Mass Tort Preemption Defense

Epiq on

After years of limited guidance, the Supreme Court has finally provided direction to lower courts on the issue of preemption when they delivered their opinion in Merck v. Albrecht. “Preemption” is a common defense used by...more

Skadden, Arps, Slate, Meagher & Flom LLP

Life Sciences Companies May Face More Scrutiny in Using FDA Documents to Dismiss Securities Cases

Following a recent decision from the U.S. Court of Appeals for the Ninth Circuit in Khoja v. Orexigen Therapeutics, Inc., plaintiffs alleging securities fraud against companies in the pharmaceutical and life sciences sector...more

Troutman Pepper

Food Litigation Trends: New and Undefined Label Claims in 2017

Troutman Pepper on

Part 1: Current Trends and Ingredient Claims - Class-action lawsuits involving the false advertising of food products continue to be one of the most active areas in class litigation. Originally published in Update...more

22 Results
 / 
View per page
Page: of 1

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