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Searching Content by William Gould from Holland & Knight ordered by Published Date Descending.
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Enforcement Update: FDA Approval And The Road to DOJ's Radar Screen
President Trump recently expressed frustration with the Food and Drug Administration's drug approval process.
United States
29 Mar 2017
2
Enforcement Update: The New Administration's Views On Marijuana Enforcement
When admonished by his mother to "Stop running in the house!", six year old Calvin, from the wonderful Bill Watterson comic strip Calvin and Hobbes, after a pause responded...
United States
13 Mar 2017
3
The New Administration's Views On Marijuana Enforcement
When admonished by his mother to "Stop running in the house!", six year old Calvin, from the wonderful Bill Watterson comic strip Calvin and Hobbes, after a pause responded, "The rule's on the books, but it would take all of their resources to enforce it." And on he ran.
United States
9 Mar 2017
4
Legal Landscape And Guidance For Companies Involved In Marijuana Activity
The FDA has been conducting an analysis of marijuana at the request of the U.S. Drug Enforcement Administration (DEA).
United States
25 Jul 2014
5
Second Circuit Vacates Pharmaceutical Misbranding Conviction On Free Speech Grounds
The U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their representatives solely for promoting a drug's off-label use.
United States
5 Feb 2013
6
Second Circuit Vacates Misbranding Conviction For Pharmaceutical Representative On First Amendment Grounds
In United States v. Caronia, No. 09-5006-cr, slip op. (2d Cir. Dec. 3, 2012), the U.S. Court of Appeals for the Second Circuit held that "the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of [a U.S. Food and Drug Administration] FDA-approved drug."
United States
7 Dec 2012
7
Government's Response to Pharmaceutical Companies' "Catch-22" Raises Additional Questions
"[W]hen a manufacturer speaks about an on-label use of its drug in a medical facility where physicians prescribe the drug off-label, the manufacturer is caught in a Catch-22: changing the drug’s labeling to add directions for the off-label use violates the Act’s criminal ‘new drug’ rule, but based on the government’s view of the FDA’s ‘intended use’ regulations, not changing the labeling to add those directions violates the Act’s criminal ‘misbranding’ rule.
United States
 
9 Feb 2012
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