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Foley & Lardner LLP

FDA Issues New Warning Regarding Compounded Ketamine

Foley & Lardner LLP on

On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more

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

$8 billion Risperdal verdict? It’s not the money, it’s the message, Big Pharma

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

When regular citizens get together in the civil justice system to deliberate difficult claims about complex matters, they may not get everything just right to the satisfaction of the disputing parties. But jurors’ wisdom and...more

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

Doctors, Big Pharma and FDA ripped for bungling control of potent painkillers

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

A steady flow of news reports shows how our nation’s opioid crisis can be fairly blamed on just about every actor in the medical field that should have known better: Big Pharma, doctors, hospitals, and regulators. It’s been a...more

Knobbe Martens

FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities

Knobbe Martens on

On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more

Foley & Lardner LLP

New Connecticut Law Allows Telemedicine Prescribing of Controlled Substances

Foley & Lardner LLP on

Connecticut has taken another step towards expanding the meaningful use of telemedicine in connection with treatment of mental health and substance use disorders. SB 302, signed by Governor Dannel Malloy and effective July 1,...more

Sheppard Mullin Richter & Hampton LLP

In a Unanimous Vote, the Opioid Crisis Response Act of 2018 Makes it Onto the Legislative Calendar

Sheppard Mullin Richter & Hampton LLP on

As previously discussed in our post from September 2017, the push for a response to the opioid crisis is gaining momentum. Enter the “Opioid Crisis Response Act of 2018.” On May 7, 2018, the Opioid Crisis Response Act of...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

Mintz - Health Care Viewpoints on

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Mintz - Health Care Viewpoints on

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

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