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  2. Drugs & Biologics

Perspectives on Drugs & Biologics

47 total results. Page 1 of 2.

News
Golden and Leongini Quoted on FDA Information Request in Country’s First OTC Daily Oral Contraceptive
November 2, 2022
Emily M. Leongini, Shoshana Golden
Partner Emily Leongini and Associate Shoshanna Golden were quoted on US Food and Drug Administration’s (FDA) request for additional information from HRA Pharma’s NDA sponsor of a proposal for the country’s first over-the-counter (OTC) daily oral contraceptive.
Alerts
Drug Development in the Metaverse
June 17, 2022
Sailesh K. Patel, Matthew T. Wilkerson
“Metaverse” is no longer a mere buzzword. Many industries are discovering and developing applications for the Metaverse, and the pharma and biotech industry is no different.
Alerts
Long COVID – Just the Facts
June 15, 2022
Robert G. Edwards, Ph.D., Wayne H. Matelski, Robert K. Carrol
The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an Alert addressing many of the inquiries we have received.
Alerts
Drug Importation Lawsuit Stays Alive, For Now
June 14, 2021
Stephanie Trunk, Erin E. Atkins
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the goal of safe importation of prescription drugs.”
Alerts
Competitors Unite to Fight COVID-19: Merck Agrees to Manufacture Johnson & Johnson Vaccine
March 15, 2021
Jeannette Carneiro McLaughlin, Justin A. Goldberg
We have seen biopharmaceutical companies around the world partnering to tackle COVID-19 in diagnostics, treatment development, vaccine development, and other relief efforts, including monetary and in-kind donations of lab equipment, instruments, and personal protective equipment (PPE).
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).
Events
Introduction to Drug Law and Regulation
April 10, 2020
Deborah M. Shelton
Food, Drug, Medical Device & Cosmetic Group Leader Deborah Shelton is serving as Curriculum Advisor for the Food and Drug Law Institute’s Introduction to Drug Law and Regulation virtual event on April 15-16.
Alerts
FDA COVID-19 Updates, Including New Program to Speed up Development of COVID-19 Treatments 
April 3, 2020
Robert G. Edwards, Ph.D.
On March 31, Health & Human Services Secretary Alex Azar announced the creation of a new FDA program, the Coronavirus Treatment Acceleration Program (“CTAP”), designed to speed up the development of life-saving treatments that have the potential to be both safe and effective.
Alerts
FDA Authorizes Emergency Use of Anti-Malarial Drugs from Strategic National Stockpile to Treat COVID-19 Patients 
April 2, 2020
Robert G. Edwards, Ph.D.
In a letter dated March 28, FDA announced it was issuing an Emergency Use Authorization for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19.
Alerts
FDA Announces Ground Rules for Investigation and Use of COVID-19 Convalescent Plasma Therapy
March 27, 2020
Robert G. Edwards, Ph.D.
Arent Fox continues to monitor the FDA activities and scientific reports on COVID-19 and the novel coronavirus.
Alerts
Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards
March 25, 2020
Deborah M. Shelton
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
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
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.
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.
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.
Alerts
Roll Hemp 2018
December 20, 2018
Emily M. Leongini
While he did not use a hemp pen like the one used by Senate Majority Leader Mitch McConnell (R-KY) to sign the conference report, President Trump signed into law the 2018 farm bill that includes a provision that legalizes hemp. Specifically, the provision would remove hemp from the federal list of c
Events
CBI’s Bio/Pharma Compliance Congress on Non-promotional Activities
December 4, 2018
Emily M. Leongini
Arent Fox FDA Associate Emily Leongini will present at CBI’s Bio/Pharma Compliance Congress on Non-promotional Activities.
Press Release
Arent Fox Attorneys Teach Graduate Business Course on Legal Aspects of Biotech
December 1, 2018
NEW YORK – Earlier this year, Yeshiva University’s Katz Graduate Business School introduced a new 36-credit Master of Science in Biotechnology Management and Entrepreneurship designed to prepare future business leaders in the life sciences to successfully navigate the launching new medical drugs.
Health Care Counsel Blog
New Sunshine Act Requirements: Trump Signs Law that Will Require Drug Manufacturers to Report Payments Made to Mid-Level Practitioners
October 25, 2018
Stephanie Trunk
President Trump signed into law a bill that expands the Open Payments reporting requirements.
Events
IBA Annual World Life Sciences Conference
June 1, 2018
Alexander H. Spiegler, Emily M. Leongini
Arent Fox Intellectual Property Partner Alex Spiegler and FDA Associate Emily Leongini will present at the International Bar Association (IBA) 6th Annual World Life Sciences Conference.
Events
Food and Drug Law Institute (FDLI) Annual Conference
May 3, 2018
Emily M. Leongini
Arent Fox Associate Emily Leongini will speak at the Food and Drug Law Institute (FDLI) Annual Conference hosted May 3-4, 2018 in Washington, DC.
Events
New York State Bar Association Food, Drug & Cosmetic Law Section Annual Meeting and Reception
January 25, 2018
Karen Ellis Carr
Arent Fox will host the reception for the New York State Bar Association’s (NYSBA’s) Food, Drug & Cosmetic Law Section Annual Meeting on January 25th, 2018 in its New York office.
Alerts
Companies Marketing CBD Products Be Warned: FDA Is Watching
November 20, 2017
Emily M. Leongini
The US Food and Drug Administration recently issued warning letters to four companies.
Alerts
FTC Holds Public Workshop to Consider If Hatch-Waxman Is Working for Prescription Drug Competition
November 13, 2017
Stephanie Trunk
On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”
Alerts
FDA Requires Pharma Companies to Certify Drug Listing Info
October 6, 2017
Stephanie Trunk, Emily M. Leongini
In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations.

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