News & Analysis as of

Health Administrative Agency Products Liability

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

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

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

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

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

by Knobbe Martens on

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

by Knobbe Martens on

The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency...more

Food and Drug Newsletter - December 2015

by Arnall Golden Gregory LLP on

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

Pro Te: Solutio Vol. 8 No. 2

by Butler Snow LLP on

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

Food Recalls Increase in First Quarter of 2015

Food producers are reporting a sharp rise in food recalls so far this year. During the first quarter of 2015, the U.S. Food and Drug Administration (FDA) published notices of 118 food recalls (excluding pet foods), and the...more

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

by Wilson Elser on

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

FDA Posts Largest-Ever Medical Device Recall

by Knobbe Martens on

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

by Morrison & Foerster LLP on

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

Summary of FDA’s Final Guidance on Dear Health Care Provider Letters

by Snell & Wilmer on

At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence, often in the form of a...more

CPSC is Now Publicly Posting “Letters of Advice” to its Website

In his keynote address at the annual conference of the International Consumer Product Health & Safety Organization (ICPHSO), Acting Chairman Adler announced that the agency had recently started posting what it calls “letters...more

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

by Holland & Knight LLP on

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

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

by Holland & Knight LLP on

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

by Burr & Forman on

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

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

Health Reform + Related Health Policy News - October 17, 2012

by Polsinelli on

In This Issue: - Top News…1 - State News…5 - Regulatory News…8 - Additional Reading…8 - Federal Register…9 - For More Information…12 - Excerpt From Top News: Congress, FDA Weigh...more

China Solicits Comments on Draft Rules for Writing Periodic Safety Update Reports

by McDermott Will & Emery on

China’s State Food and Drug Administration recently issued draft guidance on drafting and preparing Periodic Safety Update Reports for drugs and is seeking comments from the public until 16 April 2012. China’s State Food...more

Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

by Morgan Lewis on

State and federal courts reject efforts to categorize salmonella as a "communicable disease." While the quality of the United States' food supply continues to be exceptionally reliable, problems do occasionally arise....more

Par Pharmaceutical vs USA - Off-Label Promotion and the First Amendment

by Michael Walsh on

Par filed suit seeking a judgment declaring FDA’s regulations unconstitutional and preventing FDA from deeming lawful First Amendment protected speech as evidence of criminal intent. In response, FDA is seeking early...more

HCG Marketers Face Hot Pursuit by FDA, FTC

by Ifrah PLLC on

Putting a snag in New Year’s resolutions for pound-shedding, the FDA and the FTC recently sent out warning letters to several companies that sell HCG-based diet products online. (These companies include Nutri-Fusion Systems...more

Illegal Clinical Trials of Bone Cement Sends Executives to Prison

Four ex-officers of a Pa.-based manufacturer of a bone cement product were sentenced to prison for an unapproved trial that led to three deaths. Each pled guilty to a single misdemeanor count of shipping adulterated and...more

There'll Always Be Posner: Double-header

by Dechert LLP on

A great Chicagoan, Ernie Banks, was famous for saying “Let’s play two” – an expression of pure joy about the game of baseball. Another great Chicagoan, Judge Richard Posner, recently came out with a pair of opinions that...more

There They Go Again

by Dechert LLP on

A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon...more

76 Results
|
View per page
Page: of 4
Cybersecurity

Follow Health Updates on:

"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 using*

Already signed up? Log in here

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