Searching Content indexed under Food, Drugs, Healthcare, Life Sciences 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
The Amazing Story Of The Unsinkable Claim 8: How Many Lives Does A Patent Claim Have?
Decision: Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc., 914 F.3d 1366 (Fed. Cir. 2019) (LOURIE, Bryson, Wallach)
United States
19 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
A Piece Of Federal Circuit History: It's A Little Cheesy
One of the most cited decisions issued by the Federal Circuit is University of Notre Dame Du Lac v. J.C. Gourmet Food Co., Inc., 703 F.2d 1372 (Fed. Cir. 1983).
United States
11 Jun 2019
Summary Of Final Guidance On Interchangeability Of Biosimilars With Reference Products
On May 10, 2019, the U.S. Food and Drug Administration (FDA) released nonbinding final Guidance for Industry.
United States
10 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FDA Draft Guidance On Bispecific Antibody Development Programs
On April 18, 2019, FDA issued draft guidance on Bispecific Antibody Development Programs.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 Application Of Statutory Factors In Determining When A REMS Is Necessary
On April 4, 2019, FDA issued final guidance on FDA's application of the statutory factors in determining when a risk evaluation and mitigation strategy (REMS) is necessary.
United States
30 Apr 2019
Battle Of The Beers—Can Anheuser's Bud Light Ads Be Literally True But Legally False?
Beer. An alcoholic beverage traditionally made with four ingredients: water, barley, yeast, and hops. But what about corn syrup?
United States
22 Apr 2019
FDA Procedures For Handling Requests For Nonproprietary Name Suffix Review For Biological Products Newly Licensed Under Section 351 Of The PHS Act
On March 7, 2019 FDA updated the Center for Drug Evaluation and Research (CDER) Manual of Policies on Procedures (MAPP) for Nonproprietary Naming of Biological Products.
United States
1 Apr 2019
FDA Commissioner's Statement On Plans For The Orange Book
After dropping hints in recent months that he intended to use creative policy efforts to promote competition in the American pharmaceutical industry, U.S. Food and Drug Administration Commissioner Scott Gottlieb...
United States
28 Mar 2019
FDA Final Guidance On Developing Buprenorphine Treatments For Opioid Use Disorder
On February 13, 2019, FDA issued final guidance on developing depot buprenorphine products for treatment of opioid use disorder.
United States
27 Feb 2019
Patent The Internet Of Things (IoT) In The Food Industry
The "internet of things" (IoT) is revolutionizing how people live and work. Each day, the IoT grows as companies look for even more ways to connect devices with the goal of collecting and reporting
United States
14 Feb 2019
FDA Commissioner Statement About The Orange Book
On January 30, 2019, FDA Commissioner Scott Gottlieb issued a statement on FDA's efforts to enhance the utility of the Orange Book to foster drug competition.
United States
14 Feb 2019
A Tale Of Two Macs: If You Don't Provide Evidence Does A Big Mac Exist?
In a whopper of a decision, the Cancellation Division of the EU Intellectual Property Office ("EUIPO") revoked McDonald's BIG MAC EU trade mark registration.
United States
13 Feb 2019
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