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Medical Devices Pharmaceutical Industry Opioid

Knobbe Martens

FDA Releases Draft Guidance for Studies of Medical Devices for Opioid Use Disorder

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The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD).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

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

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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

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #1

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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

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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

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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

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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

BakerHostetler

FDA and Pharmacy Weekly Digest - September 2019 #3

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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

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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

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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

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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

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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

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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

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

BakerHostetler

FDA and Pharmacy Weekly Digest - June 2019 #1

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Food/Dietary Supplements - Acting FDA Commissioner Remarks on Cannabis-Derived -Ingredients in Food – Last week, the FDA held a public hearing titled “Scientific Data and Information about Products Containing Cannabis or...more

BakerHostetler

FDA and Pharmacy Weekly Digest - May 2019 #1

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Acting Commissioner Sharpless Speaks at FDLI Annual Conference – The acting commissioner covered opioids, the safety of imported foods and possible changes to the cosmetics regulatory regime during his address to attendees at...more

BakerHostetler

FDA and Pharmacy Weekly Digest - April 2019 #5

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FDA Issues Draft Guidance to Aid Companies in Initiating Voluntary Recalls – The FDA issued a draft guidance aimed at all regulated industries to help “ready their facilities and staff for possible recall situations.”...more

BakerHostetler

FDA and Pharmacy Weekly Digest - April 2019 #3

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Food/Dietary Supplements - Agencies Announce Food Waste Reduction Strategy – The FDA, USDA and EPA released a food waste strategy. ...more

BakerHostetler

FDA and Pharmacy Weekly Digest - April 2019 #2

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Sharpless Begins as FDA Acting Commissioner – On April 5, Norman E. “Ned” Sharpless, M.D., became the acting commissioner of the FDA. Previously he was the director of the National Cancer Institute....more

BakerHostetler

FDA and Pharmacy Weekly Digest - April 2019 #1

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Food/Dietary Supplements - Public Meeting on Intentional Adulteration Rule – On April 17, 2019, the U.S. Food and Drug Administration (FDA) will hold a public meeting on the draft guidance it issued related to the...more

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