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Opioid Pharmaceutical Industry Food and Drug Administration (FDA)

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FDA Releases Draft Guidance for Studies of Medical Devices for Opioid Use Disorder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The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD).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

American Conference Institute (ACI)

[Event] 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - March 14th - 15th, Washington, DC

Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more

American Conference Institute (ACI)

[Event] Controlled Substances – Regulation, Litigation, and Enforcement - July 12th - 13th, Washington, DC

The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more

Quarles & Brady LLP

FDA May Require Opioids to be Dispensed with Mail-Back Envelopes and Related Patient Education

Quarles & Brady LLP on

The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more

Wilson Sonsini Goodrich & Rosati

DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights"...

Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more

Fitch, Even, Tabin & Flannery LLP

Federal Circuit Declines to Revive Opioid Overdose Remedy

On February 10, in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed a district court’s holding that Adapt’s methods of treatment of opioid overdose is invalid as obvious. The...more

Morgan Lewis - As Prescribed

Dr. Robert Califf Confirmed to Fill FDA Commissioner Position

The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet...more

Smart & Biggar

B.C. Supreme Court declines to strike Province’s class action claims to recover healthcare costs and damages related to opioid...

Smart & Biggar on

In August 2018, the Province of British Columbia (Province) commenced a class action on behalf of itself and other provincial and federal governments against approximately 50 pharmaceutical manufacturers, wholesalers, and...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

MoFo Life Sciences

Key Takeaways From FDLI's Enforcement, Litigation, And Compliance Conference Keynote Address

MoFo Life Sciences on

FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...more

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

Nothing to see here? Consultant advises drug makers - and their regulators

When Big Pharma gets jammed up by federal regulators overseeing what may be risky prescription drugs, what to do? How about hiring the help of a powerful, secretive business consulting company - which also happens to be...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

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

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

Big Pharma is hard to rein in. Just look at two drug cases grabbing headlines.

Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits - in settling claims over distributors...more

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

For the vulnerable and injured, more proof that civil lawsuits provide key way to obtain justice

No matter what the carping critics may claim about the shortcomings of the civil justice system, when Big Tobacco, Big Pharma, and big organizations exploit and harm the vulnerable, lawsuits and what follows may provide a...more

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

Big Pharma’s twist: Billions in opioid settlements convert into huge tax breaks

While too many Americans struggle with skyrocketing prescription drug costs, so much so that a $10 insurance co-payment may be lethally dissuasive, Big Pharma firms are seeking billions of dollars in taxpayer-funded benefits...more

Cozen O'Connor

Testimony Against Flavored Tobacco | Affordable Cellular Service | McKinsey Settles Over Opioid Role

Cozen O'Connor on

2022 AG Elections- Arkansas Lt. Governor Announces Intent to Run for Attorney General- •Arkansas Republican Lieutenant Governor Tim Griffin announced that he is dropping his gubernatorial bid and is running for...more

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

Consultants apologize for opioid hype, as pharma payments take more fire

Heaps of ignominy are not in short order for parties that played sketchy roles in fostering the nation’s deadly opioid abuse and drug overdose crisis. The stain has spread now to one of corporate America’s most-favored...more

Proskauer - Minding Your Business

H.R. 4712: A “Narrowly Tailored” Obligation Under the Orphan Drug Act?

The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than...more

Steptoe & Johnson PLLC

FDA Recommends Naloxone Prescription for Patients Receiving Opioids or Medications Used to Treat Substance Use Disorder

Steptoe & Johnson PLLC on

In an attempt to reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration (“FDA”) issued a Drug Safety Communication recommending that providers discuss the availability of Naloxone, the opioid...more

Nutter McClennen & Fish LLP

Product Liability 2019 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...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

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...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

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