Search for: "U.S. Food and Drug Administration"
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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Food and Drug Administration issued draft guidance to supplement and expand existing guidance on how confirmatory evidence can be used in clinical trials.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]
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]
12 Sep 2023, 4:00 am
” That notice provided: TTB has consulted with the Food and Drug Administration (FDA) to determine whether wines aged under ocean waters would be considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. [read post]
11 Sep 2023, 8:36 pm
Food and Drug Administration v. [read post]
7 Sep 2023, 9:05 pm
Food and Drug Administration considers titanium dioxide safe, and apparently, so does the California Senate in that it’s been removed from the AB481’s list of banned substances. [read post]
7 Sep 2023, 9:01 pm
Food and Drug Administration, said the GenomeTrakr network is the result of 12 years of work. [read post]
7 Sep 2023, 3:20 am
According to the Food and Drug Administration (FDA), this outbreak affected more than 700 individuals in 46 states, resulting in nine deaths. [read post]
6 Sep 2023, 9:04 pm
Food and Drug Administration and FSIS, and Frank Yiannas, former deputy commissioner at the FDA. [read post]
