Search for: "U.S. Food and Drug Administration"
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27 Sep 2023, 8:13 pm
(a) The modifications made by the Food and Drug Administration on January 3, 2023 to the risk evaluation and mitigation strategy under section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) for mifepristone are hereby nullified. [read post]
26 Sep 2023, 9:00 pm
Food and Drug Administration (FDA) and the Canadian Food Inspection Agency (CFIA). [read post]
26 Sep 2023, 9:00 am
Food and Drug Administration (FDA) Authorized At-Home OTC COVID-19 Diagnostic Tests and Expiration Dates information page – it lists all FDA authorized at-home over-the-counter COVID-19 diagnostic tests, their use instructions, their lot numbers, as well as their expiration dates and updated expiration dates. [read post]
25 Sep 2023, 9:06 pm
The Food and Drug Administration’s first Deputy Commissioner for Human Foods, Jim Jones, started his work yesterday and sent the below letter to colleagues. [read post]
24 Sep 2023, 9:01 pm
Food and Drug Administration. [read post]
21 Sep 2023, 9:01 pm
Food and Drug Administration issued draft guidance to supplement and expand existing guidance on how confirmatory evidence can be used in clinical trials. [read post]
20 Sep 2023, 9:05 pm
Food and Drug Administration (FDA) to develop a new regulatory framework governing cybersecurity risks associated with medical devices. [read post]
20 Sep 2023, 1:17 pm
“Improperly listing patents in the Orange Book may harm competition from less expensive generic alternatives and keep prices artificially high,” the FTC said in a policy statement to pharmaceutical companies that it said was also backed by the Food and Drug Administration. [read post]
19 Sep 2023, 2:00 am
Food and Drug Administration (FDA), including grounds for issuing them, how the FDA issues an order, and how a sponsor should respond to a clinical hold order to ensure a timely review. [read post]
18 Sep 2023, 9:02 pm
Food and Drug Administration (FDA) are not uncommon where Kratom is involved. [read post]
18 Sep 2023, 9:00 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]
16 Sep 2023, 8:16 am
September 14 policy statement by the FTC on brand pharmaceutical manufacturers' improper listing of patents in the Food and Drug Administration's (FDA) 'Orange Book' On Thursday, the FTC issued a policy statement (PDF), press release, and an additional statement by Chair Lina Khan (PDF) concerning "improper" patent listings in the FDA's Orange Book. [read post]
15 Sep 2023, 5:35 pm
The products have been sold in the United States illegally because the company has not submitted the required premarket notification to the Food and Drug Administration. [read post]
15 Sep 2023, 10:26 am
Food and Drug Administration, and seek to enter the market (Tepezza and Krystexxa both enjoy monopolies already, so this was all about a stack of contingencies). [read post]
14 Sep 2023, 9:07 pm
Food and Drug Administration (FDA) since 1987 has banned the sale of raw milk across state lines. [read post]
13 Sep 2023, 7:39 pm
U.S. [read post]
13 Sep 2023, 11:54 am
Food and Drug Administration (FDA) receives approximately 100,000 medication error reports annually. [read post]
12 Sep 2023, 10:05 pm
Food and Drug Administration still considers titanium dioxide safe, and apparently, so does the California Senate, which removed it from the AB481’s list of banned substances. [read post]
12 Sep 2023, 10:39 am
Food and Drug Administration (FDA) just authorized the 2023-2024 updated mRNA Moderna and Pfizer-BioNTech COVID-19 vaccines for emergency use. [read post]
12 Sep 2023, 5:00 am
By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. [read post]
