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May 1, 2024 | 
mondaq.com | Lauren Carboni |Kyle Faget |Nathan Beaver
The U.S. Food and Drug Administration (FDA) recently doubled
down on its January 26, 2023
position that existing regulatory pathways for foods and
dietary supplements are not appropriate to manage the risks of
cannabidiol (CBD) and a new regulatory pathway is needed. Specifically, during an April 11, 2024 hearing
before the House Oversight and Accountability Committee, FDA
Commissioner Califf stated "the use of CBD raises safety
concerns, especially with long-term use.
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Apr 25, 2024 | 
jdsupra.com | Nathan Beaver |Lauren Carboni |Kyle Faget
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage the risks of cannabidiol (CBD) and a new regulatory pathway is needed. Specifically, during an April 11, 2024 hearing before the House Oversight and Accountability Committee, FDA Commissioner Califf stated “the use of CBD raises safety concerns, especially with long-term use.
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Apr 24, 2024 | 
natlawreview.com | Lauren Carboni
Skip to main content April 24, 2024 Volume XIV, Number 115 Legal Analysis. Expertly Written. Quickly Found.
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Sep 20, 2023 | 
mondaq.com | Lauren Carboni
The long-anticipated results of a recent clinical study
demonstrate the potential therapeutic benefits of psychedelic
substances. The results of the confirmatory phase 3 study to test
the efficacy and safety of
3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) for
the treatment of patients with severe post-traumatic stress
disorder (PTSD) were published on September 14 in Nature Medicine.
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Sep 19, 2023 | 
lexblog.com | Lauren Carboni
The long-anticipated results of a recent clinical study demonstrate the potential therapeutic benefits of psychedelic substances. The results of the confirmatory phase 3 study to test the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) for the treatment of patients with severe post-traumatic stress disorder (PTSD) were published on September 14 in Nature Medicine.
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Sep 19, 2023 | 
natlawreview.com | Lauren Carboni
Tuesday, September 19, 2023 The long-anticipated results of a recent clinical study demonstrate the potential therapeutic benefits of psychedelic substances. The results of the confirmatory phase 3 study to test the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) for the treatment of patients with severe post-traumatic stress disorder (PTSD) were published on September 14 in Nature Medicine.
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Jul 18, 2023 | 
jdsupra.com | Lauren Carboni |Monica R. Chmielewski |Kyle Faget
On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights considerations for sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and for clinical trials that will be conducted under an investigational new drug application (IND) specifically.
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Jul 18, 2023 | 
mondaq.com | Clara Greaney |Lauren Carboni |Monica R. Chmielewski |Kyle Faget
On June 26, 2023, the U.S. Food and Drug Administration (FDA)
issued its first draft guidance entitled Psychedelic Drugs:
Considerations for Clinical Investigations Guidance for
Industry (Guidance), which highlights considerations for
sponsors developing psychedelic drugs for treatment of medical
conditions (e.g., psychiatric disorders, substance use
disorders) and for clinical trials that will be conducted under an
investigational new drug application (IND) specifically.
-
Jul 17, 2023 | 
natlawreview.com | Lauren Carboni
On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights considerations for sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and for clinical trials that will be conducted under an investigational new drug application (IND) specifically.
-
Jul 17, 2023 | 
lexblog.com | Clara Greaney |Lauren Carboni |Monica R. Chmielewski |Kyle Faget
On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights considerations for sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and for clinical trials that will be conducted under an investigational new drug application (IND) specifically.
