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Insights on Life Sciences

344 total results. Page 7 of 14.

Alerts
Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards
March 25, 2020

FDA has issued a new Guidance to address certain challenges to clinical trials during the COVID-19 pandemic. This Guidance takes effect immediately and applies to clinical trials of drugs, biologics, and medical devices.

Alerts
FDA, TTB Announce Emergency Policies to Increase the Domestic Supply of Hand Sanitizer
March 25, 2020
Michael T. Kelly, Emily Cowley Leongini, Dan Jasnow

The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US.

Alerts
FDA Updates List of US Facilities That Perform COVID-19 Testing As of March 23
March 25, 2020
Wayne H. Matelski

FDA has just issued what it calls “FAQs on Diagnostic Testing for SARS-CoV-2” that provides information on which tests and which testing laboratories have received Emergency Use Authorization for the testing for the COVID-19 virus.

Alerts
Delay in Reporting Adverse Event Reports for FDA-Regulated Products During the Pandemic
March 25, 2020
Wayne H. Matelski

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.

Alerts
The Importation of Personal Protective Equipment for Treatment of COVID-19
March 24, 2020
Robert E. Shervette, IV

News reports show that because of the spread of the novel coronavirus (COVID-19) pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the healthcare system.

Alerts
COVID-19 Conundrum: What FDA is Doing About Urgent Need For Coronavirus Testing
March 21, 2020
Wayne H. Matelski

By now, almost everyone is aware of the dire situation that exists in the United States for testing patients with the Coronavirus.

Alerts
The Latest Science on COVID-19
March 19, 2020
Robert G. Edwards, Ph.D., Brian P. Waldman

Arent Fox has been monitoring daily updates from the top scientific journals and similar sources to get the most accurate information as soon as it is first made available. Here is a brief summary of the key issues that are of concern.

Alerts
Clinical Trial Impact from Coronavirus: New FDA Guidelines for Safety and Integrity
March 18, 2020
Kevin M. Nelson

The U.S. Food and Drug Administration (FDA) issued a guidance document today outlining its procedures for conducting clinical trials of investigational products in view of the worldwide COVID-19 outbreak.

Press Release
Arent Fox Expands Patent and Life Sciences Teams on Both Coasts
February 26, 2020

Arent Fox LLP is pleased to announce the expansion of its Patent practice and Life Sciences group with the addition of Counsels Daniel C. Stelter and Laurence H. Posorske, Ph.D. Mr. Stelter joins the firm’s San Francisco office, while Mr. Posorske joins Arent Fox in Washington, DC.

Alerts
Anticompetitive Patent-Listing Decision May Clear Patent Thicket for Generic Pharma Industry
February 24, 2020
Joel M. Wallace

The First Circuit handed the generic pharmaceutical industry an early Valentine’s Day treat earlier this month by resuscitating an antitrust suit against Sanofi by direct purchasers of insulin glargine.

The Fine Print
Legislation Introduced to Define the Term ‘Natural’ for Personal Care Products
December 11, 2019
Anthony V. Lupo, Matthew R. Mills, Emily Cowley Leongini

Last month, Representatives Sean Patrick Maloney (NY-18) and Grace Meng (NY-6) introduced the Natural Cosmetics Act that would define the term “natural” as it relates to personal care products and give the US Food and Drug Administration (FDA) authority to enforce the new requirements. 

Events
First Annual CounterFind Brand Protection Summit 2019
November 7, 2019
Pamela M. Deese

IP Partner Pamela M. Deese is a featured speaker at the Brand Protection Summit, co-hosted by CounterFind and Warner Music Group on November 7th, 2019 in New York.

Press Release
US News and Best Lawyers Rate 25 Arent Fox Practices Among Best in the Country
November 6, 2019

Twenty-five Arent Fox LLP practices have been recognized in the 2020 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.

Events
CIPA Annual Life Sciences Conference 2019
November 1, 2019
Alexander H. Spiegler

Partner Alexander H. Spiegler will present “US Case Law Update” at the CIPA Annual Life Sciences Conference 2019 on November 11, 2019.

Events
Sports, Drugs, and Rock & Roll
October 18, 2019

On October 18, Arent Fox’s New York office will host a one-of-a-kind event on behalf of the New York State Bar Association that focuses on the intersection of FDA and sports law.

Events
Taking Medicine and the IoT Head On
October 10, 2019

Please join us on October 10 for an engaging lunch program that will address the convergence of medicine and the Internet of Things.

Alerts
Three Ways the DTSA Uniquely Protects Biotech Trade Secrets in the United States
September 17, 2019
Alexander H. Spiegler

The protection of intellectual property in the biotech industry is critical. Patents are the most common form of IP protection for biotech inventions.

Press Release
Fifty Arent Fox Attorneys Named The Best Lawyers in America 2020
August 16, 2019

WASHINGTON — Fifty Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2020.

Events
The New Biotechnology Regulatory Regime
July 23, 2019
Stanley H. Abramson

Life Sciences Counsel Stan Abramson will speak on a panel at a Farm Foundation Forum about the challenges and opportunities of implementing a new biotechnology regulation review process on July 23, 2019, at the National Press Club.

Events
Farm Foundation® Forum: Gene Editing: Opportunities and Challenges
July 17, 2019
Karen Ellis Carr

Life Sciences Partner Karen Ellis Carr will speak at the Farm Foundation® Forum, “Gene Editing: Opportunities and Challenges,” at the National Press Club on July 17, 2018.

Press Release
Arent Fox Expands Food, Drug, Medical Device & Cosmetic Practice with Addition of Partner Deborah M. Shelton
July 10, 2019

Arent Fox LLP is pleased to announce the expansion of its nationally recognized Food, Drug, Medical Device & Cosmetic practice with the addition of Partner Deborah M. Shelton.

Alerts
USDA’s Proposed Revised Part 340: Key Takeaways
June 20, 2019
Karen Ellis Carr

On June 6, the US Department of Agriculture (USDA or Agency) released its proposed revision to Part 340, the regulations implementing USDA’s authority over genetically engineered (GE) organisms, including GE plants.

Alerts
FDA Announces April 25 Webinar on Genome Editing in Animals, Signaling Commitment to Implementing its Plant and Animal Biotechnology Innovation Action Plan
April 2, 2019
Karen Ellis Carr, Emily Cowley Leongini

The Action Plan is intended to clarify the agency’s science- and-risk-based approach to regulating such products with the stated goals of fostering innovation, enhancing public communication and outreach, and increasing coordination between FDA and its federal and international counterparts.

Alerts
USDA Concerned about Growing Pains With Expedited Time Frame for Hemp Rule
March 19, 2019
Emily Cowley Leongini

Last week, USDA’s Agricultural Marketing Service convened a webinar to accept public comments on implementing the hemp provisions included in the 2018 farm bill.

Events
Arent Fox Hosts 8th Annual Food Policy Impact Meeting
February 11, 2019
Karen Ellis Carr, Emily Cowley Leongini

Arent Fox hosted the Institute of Food Technologies and American Society for Nutrition’s 8th Annual Food Policy Impact meeting at the DC office on February 11-12th.

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