News & Analysis as of

Medical Devices Opioid

Knobbe Martens

FDA Releases Draft Guidance for Studies of Medical Devices for Opioid Use Disorder

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD).  According to the FDA’s press release,...more

King & Spalding

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

King & Spalding on

The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

Foley Hoag LLP - White Collar Law &...

Health Care Enforcement – A Look Ahead

This is the first post in this year’s series examining important trends in white collar law and investigations. Join us in the weeks ahead as we provide updates on new developments and emerging trends in a number of white...more

Mintz - Health Care Viewpoints

False Claims Act Settlements and Judgments Exceed $5.6 Billion in Fiscal Year 2021

The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - January 2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Patrick Malone & Associates P.C. | DC Injury...

Questions aplenty about medical device-makers paying doctors $3.6 billion

Although Big Pharma has taken deserved heat for selling its drugs by slathering doctors with cheesy tchotchkes, lavish or even cheap meals, and pricey trips, as well as lucrative consulting and speaking opportunities, medical...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2020

Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

Robins Kaplan LLP

Robins Kaplan Justice Report Winter 2020 | VOL. 14 NO. 1

Robins Kaplan LLP on

DUSTING SPRAY DEATHS AND INJURIES - Robins Kaplan LLP is investigating and litigating “dusting” cases, which arise when someone inhales—or “huffs”—compressed gas dusting spray for its intoxicating effects while driving and...more

Mintz - Health Care Viewpoints

Health Care Enforcement Year-in-Review and 2020 Outlook: Criminal Case Developments

As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the...more

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #1

BakerHostetler on

Food/Dietary Supplements - FDA Releases Final Serving Size Guidance – The guidance is intended to “help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations. ...more

BakerHostetler

FDA and Pharmacy Weekly Digest - November 2019 #2

BakerHostetler on

President Trump Announces Nomination for Next FDA Commissioner – The president nominated Dr. Stephen Hahn, chief medical executive at the University of Texas MD Anderson Cancer Center, for the position of commissioner of the...more

Patrick Malone & Associates P.C. | DC Injury...

Secrecy in drug and medical device lawsuits can imperil patients, experts say

The civil justice system, by regularly closing off and keeping secret key parts of lawsuits involving medical devices and prescription drugs, may contribute to patients’ serious injuries and deaths, according to a “special...more

BakerHostetler

FDA and Pharmacy Weekly Digest - October 2019 #5

BakerHostetler on

Food/Dietary Supplements - FDA Releases Final Rule on Calorie Labeling for Products in Vending Machines – The FDA stated, “The rule issued today finalizes the 2018 proposed rule and requires that the FOP calorie...more

Patrick Malone & Associates P.C. | DC Injury...

Billions from landmark opioids case? It’d be just a start in dealing with crisis

Tens of billions of dollars. Those sound like hefty sums. But will it ever be enough? Will, say, $50 billion offer justice and appropriate recompense to a nation wracked by an opioid and overdose crisis?...more

BakerHostetler

FDA and Pharmacy Weekly Digest - October 2019 #1

BakerHostetler on

Food/Dietary Supplements - Acting FDA Commissioner Discusses Food Safety Modernization Act (FSMA) Progress – Acting Commissioner Sharpless announced the Food Safety Dashboard as part of the FDA-TRACK, “which is one tool...more

Robinson+Cole Health Law Diagnosis

New Connecticut Legislation Affecting Healthcare Providers and Entities Effective October 1, 2019

Multiple public acts from Connecticut’s 2019 legislative session go into effect on October 1, 2019. Below is a list of public health legislation effective October 1, with links to our previous posts summarizing the acts...more

Pullman & Comley - Connecticut Health Law

Regulatory Update: New Connecticut Statutes Affecting Health Care Providers

The 2019 legislative session of the Connecticut General Assembly produced a number of new statutes that impact hospitals and other health care providers, many of which are scheduled to take effect on October 1. These Public...more

BakerHostetler

FDA and Pharmacy Weekly Digest - September 2019 #3

BakerHostetler on

Food/Dietary Supplements - FDA Issues Guidance on Fish and Fishery Products – The FDA released a draft guidance “intended to clarify steps that owners of fish and fishery products, or their representatives, can take to...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

ArentFox Schiff

CMS Releases CY 2020 Proposed Physician Fee Schedule

ArentFox Schiff on

The Centers for Medicare and Medicaid Services (CMS) recently released the CY 2020 Proposed Physician Fee Schedule....more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2019 #4

BakerHostetler on

Food/Dietary Supplements - FDA Announces Consent Decree Against Food Warehouse – A U.S. District Court in Arkansas entered a consent decree against a facility that warehoused food, drug products and medical products under...more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2019 #3

BakerHostetler on

Food/Dietary Supplements - FDA Issues Information for Food Producers Affected by Tropical Storm Barry – The FDA encouraged food producers to utilize established FDA guidance on evaluating the safety of flood-affected food...more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2019 #2

BakerHostetler on

Food/Dietary Supplements - FDA Revises Advice About Eating Fish While Pregnant – The FDA issued a revised “Advice about Eating Fish for Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children.”...more

BakerHostetler

FDA and Pharmacy Weekly Digest - June 2019 #4

BakerHostetler on

Food/Dietary Supplements - FDA Announces Guidance on Added Sugar Labeling – The FDA published a new guidance for labeling of added sugars. ...more

52 Results
 / 
View per page
Page: of 3

"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