Teva Pharmaceuticals filed suit against the United States Food and Drug Administration (FDA) alleging that its glatiramer (Copaxone) falls under the revised definition of a “biological product” and should be transitioned to the system established by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.
As we reported earlier this week, in an effort to increase the domestic supply of hand sanitizer, the US Food and Drug Administration (FDA) recently announced policies that temporarily relax certain requirements for the production of alcohol-based hand sanitizer.
FDA has issued a new Enforcement Policy that allows manufacturers of certain FDA-cleared non-invasive devices to expand their use for healthcare professionals to monitor patients remotely during the COVID-19 pandemic.
Arent Fox continues to monitor the latest scientific reports on COVID-19 and the novel coronavirus for issues that may be of general concern to our clients.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.