Perspectives on Drugs & Biologics
47 total results. Page 1 of 2.
Golden and Leongini Quoted on FDA Information Request in Country’s First OTC Daily Oral Contraceptive
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.
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.
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.”
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).
Premarket Testing of Diagnostic Medical Software Protected From Claims of Patent Infringement by § 271 Safe Harbor Defense
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-CV-06593 (N.D. Cal. Oct. 16, 2020).
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.
FDA Authorizes Emergency Use of Anti-Malarial Drugs from Strategic National Stockpile to Treat COVID-19 Patients
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.
Arent Fox continues to monitor the FDA activities and scientific reports on COVID-19 and the novel coronavirus.
Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards
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.
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.
By now, almost everyone is aware of the dire situation that exists in the United States for testing patients with the Coronavirus.
WASHINGTON — Fifty Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2020.
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
Arent Fox FDA Associate Emily Leongini will present at CBI’s Bio/Pharma Compliance Congress on Non-promotional Activities.
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.
New Sunshine Act Requirements: Trump Signs Law that Will Require Drug Manufacturers to Report Payments Made to Mid-Level Practitioners
President Trump signed into law a bill that expands the Open Payments reporting requirements.
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.
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.
On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”
In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations.