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Searching Content indexed under Trials & Appeals & Compensation by Joanne Hawana ordered by Published Date Descending.
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Eighth Circuit Issues Decision Significant For All Executives Of FDA-Regulated Businesses
In 2010, approximately 56,000 Americans fell ill with salmonellosis after consuming contaminated eggs.
United States
15 Jul 2016
2
6-Month Notice From A Biosimilar Sponsor Always Required — Says Federal Circuit
The court stated clearly that the answer to that question is "No" and that notice of commercial marketing is always required after FDA's date of licensure for the biosimilar.
United States
8 Jul 2016
3
Amarin/FDA Settlement: A Significant First Amendment Victory For Off-Label Marketing
The settlement comes after a series of high-profile losses for FDA and the DOJ in the government's attempt to prohibit and criminalize truthful off-label marketing.
United States
16 Mar 2016
4
Positive FDA Advisory Committee Vote For First Monoclonal Antibody Biosimilar – But Will Patent Dispute Delay Launch?
Tuesday, February 9th was a busy day for Korean biologics company Celltrion Inc. The company had its proposed biosimilar CT-P13 before the FDA Arthritis Advisory Committee as well as a hearing in federal court in Massachusetts.
United States
12 Feb 2016
5
First Monoclonal Antibody Biosimilar In U.S. Gets One Step Closer To FDA Approval
Yesterday, the FDA's Arthritis Advisory Committee voted 21-3 to recommend that CT-P13, Celltrion's proposed biosimilar of Janssen Biotech, Inc.'s Remicade® (infliximab) be approved for all indications.
United States
11 Feb 2016
6
First Amendment Protects Truthful Off-Label Speech By Drug Manufacturers
Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.'s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency).
United States
18 Aug 2015
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