Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Finnegan, Henderson, Farabow, Garrett & Dunner, LLP ordered by Published Date Descending.
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Considerations In Demonstrating Interchangeability With A Reference Biologic Product
Dek: Sponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product
United States
20 Aug 2019
New FDA Guidance On Biosimilar Interchangeability
On May 09, 2019, the U.S. FDA issued final guidance titled "Considerations in Demonstrating Interchangeability with a Reference Product." It is intended to assist sponsors in demonstrating
United States
22 Jul 2019
Following The Patent Dance Three Years After Sandoz
In June 2017, the Supreme Court handed down its decision in Sandoz v. Amgen—the first lawsuit brought under the Biologics Price Competition and Innovation Act (BPCIA).
United States
19 Jun 2019
FDA Issues An Update To Working Model For Software Precertification
In January 2019, FDA issued an update to the Working Model for its Software as a Medical Device ("SaMD") Precertification Program.
United States
14 May 2019
FDA Draft Guidance On Bispecific Antibody Development Programs
On April 18, 2019, FDA issued draft guidance on Bispecific Antibody Development Programs.
United States
14 May 2019
FDA Issues A 2019 Test Plan For Software Precertification
In January 2019, in conjunction with Version 1.0 of its Working Model for the Software Precertification Program,
United States
6 May 2019
FDA Issues A Regulatory Framework For Software Precertification
In January 2019, in conjunction with its Version 1.0 of the Working Model for the Software Precertification Program,
United States
6 May 2019
Lessons Learned From 23andme Inc. v. Ancestry.Com
The current trajectory of innovation is resulting in the convergence of biological and electronic discoveries into hybrid technologies that incorporate aspects of both scientific disciplines.
United States
1 May 2019
FDA Final Guidance On Immunogenicity Testing Of Therapeutic Protein Products
On January 23, 2019, FDA issued final guidance on immunogenicity testing of therapeutic protein products.
United States
4 Feb 2019
FDA Issues Guidance On Logical Observation Identifiers Names And Codes For In Vitro Diagnostic Tests
On June 15, 2018, FDA issued Guidance on Logical Observation Identifiers Names and Codes (LOINC) for in vitro diagnostic (IVD) tests.
United States
22 Jan 2019
CAFC Holds ITC Must Grant Relief Against Defaulting Respondents Under 19 U.S.C. § 1337(G)(1) In Laerdal Medical Corp. v. ITC
In Laerdal Medical Corp. v. International Trade Commission, No. 17-2445, the CAFC reversed the ITC's final determination that Laerdal failed to plead its trade dress infringement claims with adequate detail...
United States
8 Jan 2019
FDA Proposed Rule Defining "Biological Product"
If finalized, the rule would take effect on the earlier of 60 days after publication in the Federal Register or March 23, 2020.
United States
3 Jan 2019
Combine the Label with Phase III Clinical Results and a Carefully Crafted, Mirroring US Patent Application to Achieve Longer Patent Exclusivity for US Life Science Patents
The invention at issue in Sanofi v. Watson, was dronedarone, an antiarrhythmic agent directed towards the treatment of heart rhythm problems in patients with atrial fibrillation.
United States
2 Jan 2019
First Revision To Questions And Answers On Biosimilar Development
On December 11, 2018, FDA issued its fifth final guidance document related to the development of biosimilars and interchangeability products entitled Questions and Answers on Biosimilar
United States
28 Dec 2018
FDA Provides Update On Efforts To Strengthen 510(K) Program
On November 26, 2018, FDA published an outline of the numerous improvements to the 510(k) program.
United States
7 Dec 2018
FDA Issues Guidance On Benefit-Risk Factors To Consider When Determining Substantial Equivalence In Premarket Notifications
On September 25, 2018, FDA issued Guidance on benefit-risk factors to consider when determining substantial equivalence (SE) ...
United States
30 Nov 2018
FDA Issues Guidance On Unique Device Identification
FDA has a unique device identification (UDI) system designed to identify medical devices through distribution and use.
United States
29 Nov 2018
FDA Issues Draft Guidance On Management Of Cybersecurity In Medical Devices
On October 18, 2018, FDA issued draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
United States
23 Nov 2018
Puzzling Out The Patent-Eligibility Of Natural Products
Patent eligibility under Section 101 of the United States Patent Act continues to confound practitioners and create uncertainty as to the value of patents in the life sciences.
United States
23 Nov 2018
Podcast: October 2018 - Last Month At The Federal Circuit Podcast Series
Welcome to the Last Month at the Federal Circuit – a look at recent Federal Circuit decisions impacting the intellectual property community.
United States
5 Nov 2018
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