Searching Content indexed under Food and Drugs Law by Dean Fanelli Ph.D. ordered by Published Date Descending.
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Teva Sues FDA Alleging Unlawful Interpretation Of The Definition Of "First Applicant"
The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs designated as Competitive Generic Therapies.
United States
29 Oct 2018
Now Available! Seyfarth Shaw's Bioloquitur Bulletin: Drugs Available In 2018 For Generic Competition
Seyfarth Shaw is pleased to announce The BioLoquitur Bulletin: Drugs Available in 2018 for Generic Competition, published by the Life Sciences team.
United States
11 Apr 2018
FDA's Office Of Generic Drugs: 2017 Annual Report Highlights
U.S. Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, has made generic drugs and drug pricing an agency priority by emphasizing the critical value of generic drugs to public health.
United States
13 Mar 2018
Is Medical Marijuana Really Medicinal?
Despite the dearth of approved marijuana products, the term "medical marijuana" has become commonplace, and the term's prevalence continues to increase as more states legalize ...
United States
10 Nov 2017
FDA Provides New Product Specific Guidance For Development Of Certain Generic Drug Products
This article summarizes information taken from the following sources: FDA's Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA ...
United States
9 Nov 2017
Unharvested Opportunities For The Marijuana Industry – Exploiting Non-Traditional Forms Of Intellectual Property
Strong intellectual property is the cornerstone of most start-up companies, and in most cases it is the key asset utilized by companies in securing financing and investment.
United States
10 Feb 2017
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