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  1. Services
  2. Life Sciences

Insights on Life Sciences

373 total results. Page 6 of 15.

National Security Counsel
President Biden Orders 100-Day Review of America’s Supply Chains for Semiconductors, Batteries, Critical Minerals and APIs
February 26, 2021
David R. Hamill, Jessica DiPietro, Birgit Matthiesen, Kay C. Georgi

Changes are afoot for key industry sectors with complicated global supply chains.

Alerts
The Vaccines and the Variants
February 26, 2021
Wayne H. Matelski

FDA provides requirements that will allow for a much quicker authorization of “booster shots” for existing vaccines for use against variants or mutations of the coronavirus.

Alerts
Novel Coronavirus Mutations and Variants – What Do They Mean for Us?
February 24, 2021
Robert G. Edwards, Ph.D.

The novel coronavirus undergoes a mutation about once every 2 weeks, or half the rate seen in influenza.

United States Capitol Building
Alerts
Biden’s First 100 Days: Policy Changes & Your Industry
February 17, 2021
Mark A. Bloom, Lynn R. Fiorentino, David R. Hamill, David P. Grosso, Elliott M. Kroll, M. Scott Peeler, Andrew Ross, Julius A. Rousseau, III, D. Jacques Smith, Randall A. Brater, Henry Morris, Jr., Angela M. Santos, Stephanie Trunk

Arent Fox is monitoring policy changes by the Biden Administration to provide timely analysis on how they could impact your business.

Alerts
What Should Pharma Companies Expect From the Biden Administration?
January 29, 2021
Stephanie Trunk

With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway.

Alerts
Legislative Changes to FDA’s Orange Book and Purple Book Listing Requirements
January 15, 2021

Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements.

Alerts
Potential Impact of California’s Prop. 65 on Manufacturers, Distributors, and Sellers of Cannabis Products
January 15, 2021
Lynn R. Fiorentino, Debra Albin-Riley, Brian P. Waldman, Robert G. Edwards, Ph.D.

Prop 65 Counsel: What To Know

Health Care Counsel Blog
Second Judge Grants Temporary Injunction Against Favored Nation Rule
December 29, 2020
Stephanie Trunk

On December 28, 2020, Judge Vince Chhabria of the US District Court for the Northern District of California joined Judge Catherine Blake of the US District Court of the District of Maryland in enjoining the application of the Medicare Part B Most Favored Nations Reimbursement Rule.

Alerts
Update to Prop 65 Concerns Related to Roasted Nuts
December 15, 2020
Lynn R. Fiorentino, Debra Albin-Riley, Brian P. Waldman, Robert G. Edwards, Ph.D.

Prop 65 Counsel: What To Know

Alerts
Premarket Testing of Diagnostic Medical Software Protected From Claims of Patent Infringement by § 271 Safe Harbor Defense
November 24, 2020
Richard J. Berman, Michael Scarpati, Ph.D.

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-CV-06593 (N.D. Cal. Oct. 16, 2020).

Alerts
FDA Finally Authorizes a COVID-19 Home Test
November 18, 2020
Wayne H. Matelski

Late yesterday, November 17, 2020, the FDA issued an Emergency Use Authorization (EUA) to Lucira Health for an All-In-One Test Kit for prescription home use in individuals 14 years of age or older.

Alerts
EUAs for Laboratory Developed COVID-19 Tests Will No Longer Be Reviewed by the FDA
October 9, 2020
Wayne H. Matelski

The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy.

Events
FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
October 7, 2020
Karen Ellis Carr

Partner Karen Carr will serve as a panel speaker at the 2020 FDLI Annual Conference in October. Karen’s session is titled “Emerging Technologies: Regulatory Oversight of Intentional Genomic Alterations in Animals.”

Alerts
FDA Proposes to Revise “Intended Use” Regulations (Again) to Clarify that Knowledge Alone Is Not Sufficient to Establish Intent
September 28, 2020
Emily Cowley Leongini

Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a violation of the Food, Drug, and Cosmetic Act (FDCA).

Health Care Feature Story Image
Health Care Counsel Blog
HHS Proposes New Practices for Issuance of Guidance Documents
September 1, 2020
Stephanie Trunk

In a move with far reaching implications for the health care industry, the Department of Health and Human Services (HHS) recently released a proposed rule that would codify into regulation specific requirements that it and its related agencies must follow when issuing guidance to the public or regul

Press Release
EPA Approves First Long-Lasting Antiviral Product for COVID-19
August 25, 2020

On August 24, the US Environmental Protection Agency announced a groundbreaking development in efforts to combat COVID-19.

Alerts
COVID-19 Tests No Longer Need Authorization by FDA for Marketing
August 20, 2020
Wayne H. Matelski

In the Food and Drug area, we don’t often get dramatic changes in FDA policies, but an announcement from the Secretary of HHS, published on August 18, appears to be just such a dramatic change.

Press Release
53 Arent Fox Attorneys Named The Best Lawyers in America 2021
August 20, 2020

Fifty-three Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2021.

Alerts
What You Need To Know About Changes To California's Prop 65
August 14, 2020
Lynn R. Fiorentino, Debra Albin-Riley, Brian P. Waldman, Robert G. Edwards, Ph.D.

Prop 65 Counsel: What To Know

Events
Understanding Pesticide Regulation and the Ninth Circuit Dicamba Decision
July 15, 2020
Donald C. McLean

Partner Don McLean was a featured panelist in an American Agricultural Law Association webinar discussing pesticide regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well a major recent decision by the U.S. Court of Appeals for the Ninth Circuit.

Alerts
TTAB: Hemp Oil Extracts Marketed as Dietary Supplements Are Ineligible for Trademark Registration
July 8, 2020
Ross Q. Panko, Anthony D. Peluso, Emily Cowley Leongini

The United States Trademark Trial and Appeal Board (TTAB) recently affirmed a refusal to register a trademark for “hemp oil extracts” when used as an ingredient in dietary supplements.

News
A New Antitrust Approach After Humira 'Patent Thicket' Ruling
June 26, 2020
Kevin M. Nelson

Law360

Alerts
FDA Issues Guidance On What To Do if Employees Test Positive for COVID-19
June 23, 2020
Wayne H. Matelski

The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities. 

Alerts
How to Tell if Your COVID-19 Test Is Authorized by the FDA
June 18, 2020
Wayne H. Matelski

FDA’s website allows you to determine if a particular COVID-19 test has been reviewed by the FDA.

Alerts
FDA Authorizes First Genomic Sequencing COVID-19 Test
June 12, 2020
Wayne H. Matelski

On June 10, 2020, the FDA issued an emergency use authorization (EUA) for the first molecular diagnostic test that can generate information about the genomic sequence of the COVID-19 virus.

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