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16 Mar 2022, 9:02 pm
The Food and Drug Administration has posted an increase in the number of patients in an outbreak of Listeria monocytogenes infections as it continues investigations into three other outbreaks. [read post]
16 Mar 2022, 12:15 pm
The Food and Drug Administration is investigating a new outbreak of foodborne illnesses, but few details have been released. [read post]
15 Mar 2022, 12:29 pm
Food and Drug Administration (FDA) has set a date of April 22, 2022 for the previously announced meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of the Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small… [read post]
15 Mar 2022, 11:26 am
On March 7, 2022, the Center for Veterinary Medicine (CVM), which is housed within the Food and Drug Administration (FDA), announced... [read post]
14 Mar 2022, 9:03 pm
Food and Drug Administration has issued guidance on its intent not to enforce certain provisions of five rules that implement the Food Safety Modernization Act. [read post]
14 Mar 2022, 9:02 pm
The Food and Drug Administration is continuing its use of import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
14 Mar 2022, 12:01 pm
According to the Food and Drug Administration, NDMA is a known environmental contaminant found in water and foods including but not limited to meats, dairy, and vegetables. [read post]
FDA Outlines Termination Plan for COVID-19 EUAs and Enforcement Policies for Medical Devices and PPE
14 Mar 2022, 5:59 am
On February 22, 2022, the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical devices marketed pursuant to either Emergency Use Authorization (EUA) or Enforcement Policies during the COVID-19 public health emergency (PHE). [read post]
13 Mar 2022, 9:03 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
13 Mar 2022, 9:41 am
Food and Drug Administration These 10-day Deadlines Go To 11 Award - Assorted Massachusetts Agencies The Return to Sender Award - Virginia Del. [read post]
11 Mar 2022, 9:04 pm
Food and Drug Administration Dear Drs. [read post]
11 Mar 2022, 2:07 pm
Food and Drug Administration (FDA)-approved personalized therapies. [read post]
10 Mar 2022, 7:48 pm
Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for a ready-to-eat (RTE) chicken salad product containing a Food and Drug Administration (FDA) regulated salad dressing that has been recalled by the producer due to concerns that the salad dressing may contain hard plastic. [read post]
10 Mar 2022, 2:14 pm
Food and Drug Administration (FDA) or European Medicines Agency (EMA). [read post]
10 Mar 2022, 9:23 am
Food and Drug Administration (“FDA”) or European Medicines Agency (“EMA”), and falsely represented such substances were approved. [read post]
9 Mar 2022, 9:01 pm
The Food and Drug Administration is investigating three ongoing foodborne illness outbreaks. [read post]
9 Mar 2022, 9:00 pm
Food and Drug Administration, charging Diane Zollinger, through her business, Felix Custom Smoking, with violating the Federal Food, Drug and Cosmetic Act (FDCA) by distributing adulterated ready-to-eat seafood products, including fish jerky and cold- and hot-smoked salmon. [read post]
9 Mar 2022, 5:57 pm
Food and Drug Administration (FDA), the United States alleged that Diane Zollinger, through her business, Felix Custom Smoking, violated the Federal Food, Drug and Cosmetic Act (FDCA) by distributing adulterated ready-to-eat seafood products, including fish jerky and cold- and hot-smoked salmon. [read post]
9 Mar 2022, 4:58 pm
Food and Drug Administration (FDA) or European Medicines Agency (EMA) and manufactured in accordance with federal quality standards. [read post]
9 Mar 2022, 3:06 pm
Food and Drug Administration officials say the infection, which had been included in an investigation into formula produced by Abbott Nutrition, may not be linked to the company’s product. [read post]
