Administrative Agency Science, Computers & Technology Products Liability

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FDA Launches Website for Allegations Against Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) recently launched a website1 that will now make it easier to report allegations of medical device manufacturer misconduct to the agency.2 Misconduct reports were historically...more

Commercial Drones Set To Take Flight

On June 21, 2016, the Federal Aviation Administration (FAA) unveiled a landmark set of new rules for the commercial operation of small Unmanned Aircraft Systems (sUAS), more popularly known as drones. The new rules will take...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

Food and Drug Newsletter - December 2015

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

The Internet of Things and the Inevitable Collision with Product Liability PART 4: Government Oversight

The exponential growth of the Internet of Things (IoT) is far outpacing the ability of stakeholders to address safety standards and security concerns. This is not unusual as rapidly developing technology often challenges...more

Pro Te: Solutio Vol. 8 No. 2

Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

PHOs Banned in the U.S.: Landmark FDA Order Declares Partially Hydrogenated Oils No Longer Generally Regarded as Safe

On June 17, 2015, the U.S. Food and Drug Administration (FDA) issued its much-anticipated Final Determination Regarding Partially Hydrogenated Oils (Order), finding there is “no longer a consensus that partially hydrogenated...more

IP/Unfair Comp. Case Applies Buckman

The very name “intellectual property law” suggests it’s not for us. There are episodes of The Simpsons that seem too complicated for our pretty little heads. Anything deemed “intellectual” scares us away. We usually race...more

Far-Reaching Information Request on Nanoscale Chemical Substances Proposed by EPA

For the first time, and after multi-year negotiations with, and review by, the Office of Management and Budget, the U.S. Environmental Protection Agency is proposing to use its authority under the federal Toxic Substances...more

Bipartisan Senate Bill Would Introduce Largest Increase in FDA Oversight of Personal Care Products—Including Cosmetics—in over 70...

Personal care products, which include cosmetics, are a large, profitable, growth industry. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug & Cosmetic...more

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

Product Liability Update - April 2015

In This Issue: - First Circuit Holds State Law Claims Against Drug Manufacturer for Allegedly Misleading Efficacy Representations in FDA-Approved Label Preempted by Food, Drug & Cosmetic Act Because Plaintiffs’...more

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

Can The FDA Do That?

A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common....more

Preemption and Primary Jurisdiction After Pom Wonderful

After the U.S. Supreme Court decision in Pom Wonderful LLC v. The Coca-Cola Co., __ U.S. __, 134 S.Ct. 2228 (2014), fear arose among national marketers that the decision would produce a wave of class actions challenging food,...more

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

Consumer Protection Laws And Prescription Meds: A Poor Fit

Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury,...more

The FDA’s 510(k) Approval Process in Medical-Device Litigation

Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it may be that crucial nudge for a jury to tip the scales of justice for one side or the other. In...more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more

Intermediates Compliance Warning

ECHA raised serious concerns recently about the quality and compliance of 574 companies' registration dossiers, all of which relate to intermediate substances. The companies have been notified via REACH-IT and given 3 months...more

Confounding Issues about Compounding Pharmacy Regulation

Originally published in the American Health Lawyers Association, Washington, D.C. on October 17th, 2012 New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing...more

Product Liability Update -- July 2012

In This Issue: *First Circuit Affirms Judgment Against Generic Drug Manufacturer on Plaintiff’s Design Defect Claim, Holding: (i) Product May Be Found “Defective” on Proof It Is “Unreasonably Dangerous”; (ii) Design...more

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