Searching Content indexed under Food and Drugs Law by Shana Cyr ordered by Published Date Descending.
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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 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
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FDA Draft Guidance On Common Issues In Drug Development For Rare Diseases
On January 16, 2019, FDA issued draft guidance on Rare Diseases: Common Issues in Drug Development.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
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
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
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
FDA Draft Guidance On Postapproval Changes To Drug Substances
On September 10, 2018, the FDA issued draft guidance on Postapproval Changes to Drug Substances, with recommendations regarding changes to drug substance ...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
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
FDA Draft Guidance On Indications And Usage Labeling
On July 6, 2018, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist applicants in writing the Indications and Usage section of labeling for human prescription drug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
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
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
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
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
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
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
Combination Products: Regulatory And Patent Issues You Should Consider Now
Products involving combinations of drugs, biological products, and medical devices are becoming increasingly prominent. Combination products can involve components that are physically...
United States
31 Mar 2017
Clinical Trials Conducted With A Reasonable Expectation Of Confidentiality Do Not Constitute Public Use Under 35 U.S.C. § 102(B)
In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., No. 12-1428, the Federal Circuit reversed the district court's grant of SJ of invalidity based on prior public use and remanded the case for further proceedings.
United States
17 Jul 2013
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