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15 May 2020, 11:59 am
In February 2020, the maker of Beviq and Belviq XR—Japanese drug manufacturer Eisai—announced that it was voluntarily pulling the drug from the market upon the request of the Food and Drug Administration (FDA). [read post]
15 May 2020, 8:21 am
Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). [read post]
14 May 2020, 9:05 pm
Food and Drug Administration granted emergency use authorization to the Quidel Corporation, a pharmaceuticals company based in San Diego, California, to manufacture and market the first antigen test for coronavirus. [read post]
14 May 2020, 2:55 pm
Food and Drug administration. [read post]
13 May 2020, 8:09 am
All four witnesses at the hearing, Fauci, CDC Director Robert Redfield, Food and Drug Administration Commissioner Dr. [read post]
13 May 2020, 1:42 am
The abstract provides: Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in... [read post]
12 May 2020, 10:00 pm
As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic. [read post]
12 May 2020, 10:00 pm
As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic. [read post]
12 May 2020, 10:00 pm
As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic. [read post]
12 May 2020, 10:00 pm
As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic. [read post]
12 May 2020, 10:00 pm
As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic. [read post]
12 May 2020, 9:05 pm
Food and Drug Administration (FDA) looks to previous COVID-19 patients as a potential source for a more effective therapy. [read post]
12 May 2020, 9:03 pm
The Food Allergen Labeling and Consumer Protection Act (FALCPA) in the United States requires the Food and Drug Administration to name “major allergens, which must be specifically declared on product labeling. [read post]
12 May 2020, 9:00 pm
As restaurants and other retail food establishments begin to reopen around the country, trade associations and the US Food and Drug Administration (FDA) have both issued guidance for retail food establishments that provide direction, checklists, and best practices for reopening while the country emerges from the coronavirus (COVID-19) pandemic. [read post]
12 May 2020, 4:31 pm
The recall covers a variety of sizes of packages of the fresh basil, all of which carries a label with 112 and “Product of Colombia, according to the company’s recall notice posted be the Food and Drug Administration. [read post]
12 May 2020, 1:04 pm
Fauci was the star witness at the hearing, testifying alongside Food and Drug Administration Commissioner Stephen Hahn, Centers for Disease Control and Prevention Director Robert Redfield, and Adm. [read post]
12 May 2020, 11:26 am
Food & Drug Administration (FDA). [read post]
12 May 2020, 11:26 am
Food & Drug Administration (FDA). [read post]
12 May 2020, 10:23 am
We previously wrote blog posts here and here about sets of such letters, and our colleague, Marissa Koblitz Kingman, recently wrote an alert about the Department of Justice (DOJ) and Food & Drug Administration (FDA) closely monitoring such conduct as well. [read post]
12 May 2020, 9:59 am
Food and Drug Administration (FDA) announced its process for making COVID-19-related Guidance Documents available for public comment. [read post]
