Search for: "UNITED STATES 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Food and Drug Administration issued draft guidance to supplement and expand existing guidance on how confirmatory evidence can be used in clinical trials.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]
19 Sep 2023, 3:34 am
Specifically, the statute would be amended to require NDA sponsors to: (i) certify to the Food and Drug Administration that the information described in subparagraph (B) that is submitted to the Secretary is complete and consistent with the information such sponsor or holder provided to the United States Patent and Trademark Office and any communications such sponsor or holder had with the United States Patent and Trademark… [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, 8:28 am
We are urging the Food and Drug Administration to demand scientific backing for AI tools that claim to provide therapy or other health care services to consumers. [read post]
16 Sep 2023, 8:16 am
August 25, 2023 decision by the United States Court of Appeals for the District of Columbia Circuit in FTC v. [read post]
16 Sep 2023, 4:28 am
The 46 most popular New York lawblogs of the 2,321 lawblogs in the United States, for "all times" listed by Justia this week. [read post]
16 Sep 2023, 4:28 am
The 46 most popular New York lawblogs of the 2,321 lawblogs in the United States, for "all times" listed by Justia this week. [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]
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]
10 Sep 2023, 8:30 pm
NYT via Chicago Tribune – “The latest COVID-19 boosters are expected to be approved by the Food and Drug Administration as early as Monday, arriving alongside the seasonal flu vaccine and shots to protect infants and older adults from RSV, a potentially lethal respiratory virus. [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]
6 Sep 2023, 4:02 am
” ∎ A federal judge recently found that the Biden administration had orchestrated “the most massive attack against free speech in United States history. [read post]
4 Sep 2023, 5:44 am
(Please note that these figures do not include state court securities class action lawsuit filings.) [read post]
FDA sends warning letters to infant formula manufacturers, unveils Cronobacter history in facilities
31 Aug 2023, 6:13 am
Food and Drug Administration (FDA) has escalated efforts to ensure the safety of infant formula production by issuing warning letters to three major manufacturers: ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. [read post]
30 Aug 2023, 9:00 pm
Food and Drug Administration, and the Food Safety and Inspection Service of the United States Department of Agriculture—teamed up in 2011 to create the Interagency Food Safety Analytics Collaboration (IFSAC). [read post]
24 Aug 2023, 1:17 pm
Food and Drug Administration, a key player in promoting these outdated tests, to shift toward non-animal test methods. [read post]