Posts tagged with: "fda"
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11 Apr 2024, 10:00 pm
The article notes that while awaiting further guidance from the FDA, affected manufacturers should consider steps such as assembling internal data and possibly contacting the FDA for product-specific discussions. [read post]
11 Apr 2024, 10:00 pm
The article notes that while awaiting further guidance from the FDA, affected manufacturers should consider steps such as assembling internal data and possibly contacting the FDA for product-specific discussions. [read post]
11 Apr 2024, 10:00 pm
The article notes that while awaiting further guidance from the FDA, affected manufacturers should consider steps such as assembling internal data and possibly contacting the FDA for product-specific discussions. [read post]
11 Apr 2024, 9:05 pm
“The FDA may issue advisory action letters, which include Untitled and Warning Letters, or take other actions to notify firms of violations to encourage voluntary compliance,” according to the FDA spokesperson. [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, 9:00 am
On April 4, 2024, the Food and Drug Administration (FDA) issued its “New Dietary Ingredient Notification Master Files for Dietary Supplements: Guidance for Industry” (“Draft Guidance”). [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]
11 Apr 2024, 4:00 am
In his guest post on this blog last week, Professor Sobkowski critiqued Jesse Wegman's New York Times op-ed discussing the "crisis in teaching constitutional law. [read post]
10 Apr 2024, 9:06 pm
The Food and Drug Administration (FDA) confirmed the elevated lead levels in the recalled applesauce, with FDA officials suspecting intentional contamination. [read post]
10 Apr 2024, 9:05 pm
The FDA has begun traceback efforts, but it did not report what food or foods are being traced. [read post]
10 Apr 2024, 9:04 pm
See the FDA page for recall notices. [read post]
10 Apr 2024, 10:44 am
The FDA is working to drop the discriminatory ban on sperm donation by gay men. [read post]
10 Apr 2024, 10:43 am
Upon resigning his position in protest, Farinella broadcast his concerns by filing a whistleblower complaint with the FDA, sharing the complaint with other regulators and members of Congress, and retaining a raft of documents evidencing Choice Canning’s nefarious activities. [read post]
10 Apr 2024, 9:50 am
Novo Nordisk is the only FDA-approved manufacturer of semaglutide. [read post]
10 Apr 2024, 7:48 am
The FDA has discouraged the National Association of Boards of Pharmacy from compounding Ozempic, Wegovy, and Rybelsus. [read post]
10 Apr 2024, 5:27 am
Federal regulation and enforcement of existing FDA regulations are also minimal. [read post]
9 Apr 2024, 9:05 pm
” The FDA conducted a similar sampling and testing program in 2021 and 2022. [read post]
9 Apr 2024, 9:01 pm
Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. [read post]
9 Apr 2024, 7:12 pm
The labels are modeled after the FDA nutrition labels and are intended to help consumers comparison shop for the internet service plan that will best meet their needs and budget. [read post]
