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21 Sep 2021, 9:02 pm
Food and Drug Administration has announced the reorganization of the agency’s information technology, data management and cybersecurity functions into the new Office of Digital Transformation (ODT). [read post]
21 Sep 2021, 1:25 pm
It begins with this introduction: During routine surveillance, the US Food and Drug Administration (FDA) Division of Pharmacovigilance identified postmarketing cases of Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) associated with [Padcev (enfortumab vedotin)] from the FDA Adverse Event Reporting System (FAERS). [read post]
21 Sep 2021, 12:02 pm
No other identifying codes were included in the company’s recall notice, which was posted by the Food and Drug Administration. [read post]
21 Sep 2021, 10:55 am
Ultimately, the administration is planning to create a centralized “mission control” that would work to coordinate resources and expertise from multiple agencies within the Department of Health and Human Services like the National Institutes of Health, Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority (a component of the office of the Assistant Secretary for Preparedness and Response), Food and Drug… [read post]
20 Sep 2021, 9:05 pm
The FSIS and the Food and Drug Administration had a public meeting in October 2018 on labeling cultured food products derived from livestock and poultry tissue. [read post]
20 Sep 2021, 9:01 pm
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
20 Sep 2021, 8:48 pm
Food and Drug Administration approved the first biosimilar drug for treating macular degeneration under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. [read post]
20 Sep 2021, 1:00 pm
The report found that the “extensively drug-resistant strains have been associated only with dogs. [read post]
20 Sep 2021, 12:58 pm
On September 17, 2021, the US Food and Drug Administration’s (“FDA”) Vaccines and Related Biological Products Advisory Committee rejected Pfizer’s application for the booster shot of its COVID-19 vaccine for all individuals. [read post]
20 Sep 2021, 9:25 am
” The proposed rule would also repeal the MCIT pathway that would permit faster Medicare coverage of medical devices designated as breakthrough by the Food and Drug Administration (“FDA”). [read post]
20 Sep 2021, 7:41 am
On April 1, 2020, the US Food and Drug Administration (FDA) announced that it was requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. [read post]
20 Sep 2021, 7:41 am
On April 1, 2020, the US Food and Drug Administration (FDA) announced that it was requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. [read post]
20 Sep 2021, 7:41 am
On April 1, 2020, the US Food and Drug Administration (FDA) announced that it was requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. [read post]
19 Sep 2021, 9:05 pm
The Food and Drug Administration directly performed 3,500 human food manufacturing inspections and contracted with states for another 4,000. [read post]
19 Sep 2021, 9:03 pm
Sweeteners like aspartame, sucralose, acesulfame-K, saccharin, and various sugar alcohols were approved by the Food and Drug Administration (FDA) as food additives until the late 1990s. [read post]
19 Sep 2021, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
19 Sep 2021, 9:42 am
Administrative penalties being imposed. [read post]
17 Sep 2021, 2:44 pm
The Food and Drug Administration worked on traceback, but could not identify a specific flavor or brand of cake mix as the source of the pathogen. [read post]
17 Sep 2021, 12:29 pm
The customer was not named in the company’s recall notice posted by the Food and Drug Administration. [read post]
17 Sep 2021, 10:22 am
The Food and Drug Administration’s independent panel on vaccines is meeting today to discuss booster shots of the Pfizer vaccine, according to the New York Times. [read post]
