News & Analysis as of

Adverse Events

Vinson & Elkins LLP

When You Walk Through a Storm: Legal Implications of Adverse Weather on Construction Contracts

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The recent extreme weather events in the UAE, characterised by unprecedented rain and flooding, serve as a stark reminder of the broader implications such severe weather can have on construction projects. We explore these...more

Epstein Becker & Green

Unpacking Averages: Adverse Events for Device-Lead Combination Products

Combination products present a tremendous opportunity to improve health outcomes, because they leverage multiple disciplines.  If we were, for example, to focus on drugs alone with little thought to how they might be...more

Venable LLP

Prepare Now for the New FDA Requirements for Cosmetics Companies

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Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more

Harris Beach PLLC

Federal Government Issues Toolkits Addressing Adverse Events in Health Care Facilities

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The U.S. Department of Health and Human Service’s Office of Inspector General published two Adverse Events Toolkits on July 6 to assist health care providers, government agencies and researchers identify and measure adverse...more

Epstein Becker & Green

Unpacking Averages: Success Rates for FDA FOIAs by Topic and Requester

In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. I looked at response times and then started to dive into the topics that requesters were asking...more

Nutter McClennen & Fish LLP

Product Liability 2022 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2022. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more

MoFo Life Sciences

Congress Expands FDA Authority Over Cosmetics Regulation

MoFo Life Sciences on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug...more

Dechert LLP

Not Prescription, Not Merely Over the Counter: FDA Proposes a Novel Category of Drugs

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In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Vicente LLP

Financing Adaptogenic Mushroom Companies: Seven Basic Regulatory Points to Understand

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Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...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

Jackson Lewis P.C.

FDA And CDC Issue Warnings Regarding Health Risks Of Using Delta-8 THC Products

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The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention issued warnings to the public regarding the potential health risks of using Delta-8 THC products on September 14, 2021...more

BCLP

Risk factor reminders for upcoming 10-Qs

BCLP on

As companies prepare upcoming periodic reports, they should focus on carefully reviewing and updating their risk factors. Some of the considerations may include...more

Jackson Lewis P.C.

Does the Workers’ Compensation Act Bar BIPA Claims? Illinois Supreme Court Will Weigh In

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The Illinois Supreme Court recently agreed to hear an appeal of an Appellate Court’s decision addressing whether an employee’s claim for damages under Illinois’s Biometric Information Protection Act is preempted by the...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Faegre Drinker Biddle & Reath LLP

California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal...

Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer,...more

K&L Gates LLP

COVID-19: FDA Warning Letters Address Fraudulent Products and Failures to Meet EUA Requirements

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In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under...more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under...

AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA...more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

Hogan Lovells on

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Mintz - Health Care Viewpoints

Update on FDA’s Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from...

As we discussed in our last update on the Food and Drug Administration’s Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will...more

Mintz - Health Care Viewpoints

And Now For Something Completely Different: FDA Actions to Alleviate Regulatory Burdens For Product Sponsors During the COVID-19...

We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public...more

Morgan Lewis

FDA Issues Guidance on Postmarket Adverse Event Reporting During Pandemics

Morgan Lewis on

In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more

Searcy Denney Scarola Barnhart & Shipley

FDA Takes Strong Action to Protect Patients — Breast Institute at JFK Medical Center

West Palm Beach, Florida - The US Food and Drug Administration (FDA), has recently taken the extraordinary step of requiring The Breast Institute at the JFK Medical Center North, located at 2201 45th Street in West Palm...more

ArentFox Schiff

Delay in Reporting Adverse Event Reports for FDA-Regulated Products During the Pandemic

ArentFox Schiff on

FDA has just published a new Guidance that will allow for the suspension of reporting of certain adverse event reports while the COVID-19 pandemic continues. This Guidance takes effect immediately and applies to postmarketing...more

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