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Searching Content by Shana Cyr from Finnegan, Henderson, Farabow, Garrett & Dunner, LLP ordered by Published Date Descending.
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1
U.S. Patent Rights: Think Twice Before Disclosing Your Invention
Cautionary tales of inventors who have risked their own U.S. patent rights provide valuable insight for scientists in developing their own best practices.
United States
15 Apr 2019
2
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
3
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
4
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
5
FDA Draft Guidance On Common Issues In Drug Development For Rare Diseases
On January 16, 2019, FDA issued draft guidance on Rare Diseases: Common Issues in Drug Development. The FDA intends the guidance to help sponsors conduct more efficient ...
United States
29 Jan 2019
6
Five Most Popular IP FDA Blog Posts From 2018
Happy New Year! In case you missed them, here are our five most popular posts from 2018. This has been an exciting year for the Finnegan IP FDA Blog ...
United States
17 Jan 2019
7
FDA Draft Guidance On The BPCIA "Deemed To Be A License" Provision - Questions And Answers
On December 11, 2018, FDA issued draft guidance on questions and answers about the "deemed to be a license" provision of BPCIA.
United States
2 Jan 2019
8
FDA Final Guidance On The BPCIA "Deemed To Be A License" Provision
On December 11, 2018, FDA issued final guidance on interpreting the "Deemed to be a License" provision of BPCIA. The guidance provides FDA's interpretation ...
United States
2 Jan 2019
9
Podcast: Navigating Orange Book Listings
The Drug Price Competition and Patent Term Restoration Act of 1984–also known as the Hatch-Waxman Act–amended patent law ...
United States
6 Nov 2018
10
Four Ways To Show Nonobviousness Of ADC Inventions
When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000, only a handful of patent applications claiming ADCs had been published.
United States
18 Oct 2018
11
FDA Draft Guidance On Postapproval Changes To Drug Substances
On September 10, 2018, the FDA issued draft guidance on Postapproval Changes to Drug Substances, with recommendations regarding changes to drug substance ...
United States
28 Sep 2018
12
FDA Final Guidance On Physiologically Based Pharmacokinetic Analyses
On September 4, 2018, the FDA issued final guidance on Physiologically Based Pharmacokinetic Analyses — Format and Content.
United States
17 Sep 2018
13
When Do Collaborators Become Coinventors?
Every invention begins with an inventor, someone who birthed an idea, solved a problem, or refined an existing idea to create something new.
United States
23 Aug 2018
14
FDA Draft Guidance On Indications And Usage Labeling
On July 6, 2018, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist applicants in writing the Indications and Usage section of labeling for human prescription drug
United States
20 Aug 2018
15
SaMD Series: The Interplay Between IP And FDA Submissions
Software as a Medical Device – also referred to as SaMD – is one of the fastest growing innovations in the medical device industry
United States
6 Aug 2018
16
Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
NDAs must be accompanied by certain patent information, which the FDA then lists in its Approved Drug Products with Therapeutic Equivalence Evaluations publication.
United States
20 Jul 2018
17
FDA Provides Guidance On Classifying Medical Products
The Food and Drug Administration (FDA) recently issued final guidance on the classification of medical products. FDA, Final Guidance for Industry and FDA Staff, Classification of Products ...
United States
12 Dec 2017
18
Dead Zone: Are Your Biological Products Ready For FDA's Regulatory Transition?
On March 23, 2020, hundreds of approved and pending applications for biological products will face a regulatory transition as the U.S. Food and Drug Administration (FDA) implements...
United States
6 Jun 2017
19
Dead Zone: Are Your Biological Products Ready For FDA's Regulatory Transition?
On that date, FDA will replace all approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for biologics with biologic license applications (BLAs) or abbreviated...
United States
1 Jun 2017
20
FDA Issues Its First Postmarketing Safety Reporting Regulations For Combination Products
The Food and Drug Administration (FDA) recently published a final rule setting forth the first postmarketing safety reporting regulations for combination products that have received FDA...
United States
31 Mar 2017
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