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21 Apr 2024, 9:05 pm
Food and Drug Administration has announced a priority review of the first psychedelic new drug indication—MDMA-assisted therapy for PTSD. [read post]
21 Apr 2024, 9:03 pm
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. [read post]
19 Apr 2024, 11:20 am
According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on March 21, 2024, and is ongoing. [read post]
18 Apr 2024, 9:01 pm
The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
18 Apr 2024, 12:52 pm
Consider the Food and Drug Administration’s Regulations 21 C.F.R. 801.415 is a regulation of the Food and Drug Administration (“FDA”), which provides: “Ozone is a toxic gas with no known useful medical application in specific adjunctive, or preventative therapy. [read post]
17 Apr 2024, 9:05 pm
Food and Drug Administration (FDA) for new drugs. [read post]
16 Apr 2024, 9:05 pm
Food and Drug Administration—about if and how we want to decriminalize psychedelics.The post Are Psychedelics Safe Enough for Recreational Use? [read post]
16 Apr 2024, 9:04 pm
The new approach by the Food and Drug Administration is designed to provide post-incident response action. [read post]
16 Apr 2024, 3:44 pm
Food and Drug Administration of the outbreak on April 9. [read post]
16 Apr 2024, 8:42 am
Regeneron Pharmaceuticals and Ocular Therapeutix teamed up to file their own amici curiae brief in support of Salix, in which they attributed the increasing use of clinical trial protocol summary disclosures as evidence of a “reasonable expectation of success” in the obviousness analysis to the enactment in 2007 of the Food and Drug Administration Amendments Act, which greatly expanded the number of trials requiring disclosure, which was… [read post]
15 Apr 2024, 9:05 pm
Food and Drug Administration (FDA) in 2019, psychedelics and psychedelic-assisted therapy are not typically covered by insurance. [read post]
15 Apr 2024, 9:01 pm
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
14 Apr 2024, 9:05 pm
Drug Enforcement Administration. [read post]
13 Apr 2024, 3:33 pm
The FDA’s actions led the drug companies voluntarily to withdraw PPA-containing products. [read post]
