News & Analysis as of

Drug Safety

Napoli Shkolnik

What Is Polypharmacy And Why Should You Care?

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Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts....more

Foley & Lardner LLP

FDA: New Guidance for Non-interventional Studies of Drug Safety and Effectiveness

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The U.S. Food and Drug Administration (FDA) has recently issued guidance for sponsors and investigators interested in submitting a non-interventional study, commonly known as an observational study, to contribute evidence of...more

Quarles & Brady LLP

New California Law Affects Pharmacy Operations, Staffing Ratios, And Much More

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On October 8, 2023, California Governor Gavin Newsom signed Assembly Bill 1286 into law. The new law, sponsored by Assemblymember Matt Haney and the California Board of Pharmacy, aims to reduce medication errors and...more

Faegre Drinker Biddle & Reath LLP

Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...more

International Cannabis Bar Association...

[Webinar] Safe Access to Medical Cannabis: State of the States 2023 - February 1st, 2:00 pm - 3:00 pm EST

Is access to medical cannabis expanding? Or is adult use overtaking medical cannabis? Abbey Roudebush will present the results of Americans for Safe Access’s annual State of the State report....more

Rodemer Kane Attorneys at Law

Drug-Free Zones In Colorado - How Do They Work?

While marijuana is both medically and recreationally legal in Colorado, there are still areas in the state that are considered to be no drug zones. Marijuana isn’t the only drug in Colorado, however, and drug crimes extend to...more

Console and Associates, P.C.

The Use of Depakote by Pregnancy Women Linked to Serious Birth Defects

Over ten years ago, the Food and Drug Administration (FDA) determined that pregnant women who take Depakote (valproate) have a much higher chance of giving birth to a baby who suffers low IQ or a birth defect. In response,...more

International Cannabis Bar Association...

[Webinar] Safe Access to Medical Cannabis: State of The States - January 19th, 11:00 am - 12:00 pm PST

Since 2014, Americans For Safe Access’s annual State of the States report has assessed the strength of medical cannabis programs by assigning grades to each of the 50 states, the District of Columbia and the U.S. territories....more

Console and Associates, P.C.

Truvada Lawsuit Update

What You Need to Know About Kidney Damage and Bone Loss Claims - For individuals who either live with or are at risk of contracting HIV, a medication that provides both (partial) treatment of HIV symptoms and pre-exposure...more

Foley Hoag LLP

Caught in FDA’s Crosshairs: Delta-8 THC Products Invite Increased Scrutiny

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The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more

Bennett Jones LLP

B.C. Court of Appeal Provides its First Pronouncement on Sequencing Issues

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The B.C. Court of Appeal’s decision in British Columbia v The Jean Coutu Group (PJC) Inc., 2021 BCCA 219, is the first time the B.C. Court of Appeal has weighed in on class action sequencing issues. The core issue on appeal...more

American Conference Institute (ACI)

[Virtual Event] Advanced Legal, Regulatory and Compliance Forum on Over the Counter Drugs - February 26th, 9:00 am - 5:45 pm EST

A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...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

Steptoe & Johnson PLLC

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

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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

Searcy Denney Scarola Barnhart & Shipley

Did Bayer Hide Behind Sealed Court Documents To Tout Essure?

Contraceptive Is Linked to Injuries and Deaths and Now Is the Subject of Lawsuits - Bayer, the company that manufactured and marketed the dangerous birth-control device Essure, is looking more and more like a bad actor as...more

Buckingham, Doolittle & Burroughs, LLC

Hydroxychloroquine and Chloroquine: What We Know About Off-Label Use of Drugs and Potential Malpractice Claims in Ohio

On April 24, 2020, the FDA issued a Drug Safety Communication about the known side effects of hydroxychloroquine and chloroquine – the antimalarial drugs being used to treat Covid-19. These side effects include serious and...more

Sheppard Mullin Richter & Hampton LLP

Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality

The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) within the US Food and drug Administration (FDA) published its annual “Report on the Sate of Pharmaceutical Quality” last week....more

Smart & Biggar

Rx IP Update - April 2019

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PMPRB amendments expected to come into force no earlier than Spring 2020 - On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief...more

Goodwin

FDA’s New Draft Biologic Naming Guidance

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On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”). According to FDA’s announcement the Naming Guidance reflects FDA’s current...more

BakerHostetler

FDA Launches DSCSA Pilot Project Program, Supports Use of Blockchain Technology

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On Feb. 7, 2019, the U.S. Food and Drug Administration (FDA) published a press release and on the following day published an accompanying notice in the Federal Register announcing a Pilot Project Program Under the Drug Supply...more

Searcy Denney Scarola Barnhart & Shipley

Is the FDA Broken? — Uloric Cardiac Risk Issues

Was Uloric Approval the Safe Decision? Attempts in 2005 and 2006 to obtain government-approval to sell Uloric were denied by the FDA due to concerns about research data that showed a slight elevation in the risks of death...more

Searcy Denney Scarola Barnhart & Shipley

FDA Takes Action on Opioids Labeling — It’s about education

Opioid Education - The U.S. Food and Drug Administration (FDA) crept cautiously closer to curbing the opioid crisis by approving sweeping changes as to how the prescription drugs are labeled. Going forward, such...more

Hogan Lovells

FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A

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Last week, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to help pharmaceutical trading partners understand their compliance obligations...more

Mintz - Health Care Viewpoints

FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring

In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval...more

Holland & Knight LLP

FDA Announces Modernization of Drug Review Process and Operations

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On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more

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