Perspectives on Prescription Drugs, Biologics & Diagnostics
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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.
The novel coronavirus undergoes a mutation about once every 2 weeks, or half the rate seen in influenza.
Mark A. Bloom, Lynn R. Fiorentino, David R. Hamill, David R. Hanke, Marwa M. Hassoun*, David P. Grosso, Elliott M. Kroll, J.H. Jennifer Lee, 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.
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.
Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements.
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.
Prop 65 Counsel: What To Know
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-CV-06593 (N.D. Cal. Oct. 16, 2020).
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.
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.
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.”
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).
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
On August 24, the US Environmental Protection Agency announced a groundbreaking development in efforts to combat COVID-19.
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.
Fifty-three Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2021.
Prop 65 Counsel: What To Know
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.
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.
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.
FDA’s website allows you to determine if a particular COVID-19 test has been reviewed by the FDA.
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.
FDA has yet again revised its Enforcement Policy for the US importation and distribution of face masks and respirators during the COVID-19 pandemic.
The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization (EUA) is issued for the test.