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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Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs).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Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs).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Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs).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Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs).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Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs).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Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs).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]
11 Apr 2024, 10:00 pm
In an article written for Law360 , partners Rebecca Dandeker and Aliza Karetnick and associate Rachel Lamparelli discuss a citizen petition to the US Food and Drug Administration (FDA) and litigation tied to concerns about the presence of the chemical benzene in acne products containing benzoyl peroxide. [read post]
11 Apr 2024, 10:00 pm
In an article written for Law360 , partners Rebecca Dandeker and Aliza Karetnick and associate Rachel Lamparelli discuss a citizen petition to the US Food and Drug Administration (FDA) and litigation tied to concerns about the presence of the chemical benzene in acne products containing benzoyl peroxide. [read post]
11 Apr 2024, 10:00 pm
In an article written for Law360 , partners Rebecca Dandeker and Aliza Karetnick and associate Rachel Lamparelli discuss a citizen petition to the US Food and Drug Administration (FDA) and litigation tied to concerns about the presence of the chemical benzene in acne products containing benzoyl peroxide. [read post]
11 Apr 2024, 10:00 pm
In an article written for Law360 , partners Rebecca Dandeker and Aliza Karetnick and associate Rachel Lamparelli discuss a citizen petition to the US Food and Drug Administration (FDA) and litigation tied to concerns about the presence of the chemical benzene in acne products containing benzoyl peroxide. [read post]
11 Apr 2024, 10:00 pm
In an article written for Law360 , partners Rebecca Dandeker and Aliza Karetnick and associate Rachel Lamparelli discuss a citizen petition to the US Food and Drug Administration (FDA) and litigation tied to concerns about the presence of the chemical benzene in acne products containing benzoyl peroxide. [read post]
11 Apr 2024, 10:00 pm
In an article written for Law360 , partners Rebecca Dandeker and Aliza Karetnick and associate Rachel Lamparelli discuss a citizen petition to the US Food and Drug Administration (FDA) and litigation tied to concerns about the presence of the chemical benzene in acne products containing benzoyl peroxide. [read post]
11 Apr 2024, 9:05 pm
Frank Yiannas, the former deputy commissioner of food policy and response at the Food and Drug Administration, recently gave Food Safety News insights into Rule 204 of the Food Modernization Act. [read post]
11 Apr 2024, 1:15 pm
The CAFC also affirmed an order of the district court that instructed the Food and Drug Administration (FDA) that the effective approval date of generic company Norwich’s Abbreviated New Drug Application (ANDA) may not precede the expiration dates of the claims of three other Salix patents that were found to be valid and infringed by Norwich. [read post]
11 Apr 2024, 1:15 pm
The CAFC also affirmed an order of the district court that instructed the Food and Drug Administration (FDA) that the effective approval date of generic company Norwich’s Abbreviated New Drug Application (ANDA) may not precede the expiration dates of the claims of three other Salix patents that were found to be valid and infringed by Norwich. [read post]
11 Apr 2024, 6:25 am
According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on Feb. 15, 2024, and is ongoing. [read post]
