Search for: "United States Food and Drug Administration"
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5 Dec 2022, 4:15 pm
The United States Food, Drug, and Cosmetic Act (“FD&C Act”) is a set of regulations that, among other things, vests authority in the U.S. [read post]
30 Nov 2022, 9:07 pm
” ” The petition states that the Food and Drug Administration (FDA) defines a product for personal importation as a product, not for further sale or distribution into U.S. commerce, and that the products may be carried in baggage or shipped by courier or international mail. [read post]
30 Nov 2022, 6:56 pm
Last month the United States Court of Appeals for the Second Circuit affirmed the district court’s decision to dismiss a False Claims Act (FCA) (21 U.S.C 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A., and Grifols Shared Services as defendants (collectively, “Grifols”) concealed and submitted falsified information to the United States Food and Drug Administration (FDA) to… [read post]
30 Nov 2022, 5:00 am
New drugs cannot be marketed in the United States until the FDA conducts a thorough and expert review and determines that the drug is safe and effective for its proposed use. [read post]
30 Nov 2022, 4:18 am
COVID-19 COVID-19 has infected over 98.676 million people and has now killed over 1.08 million people in the United States, according to data compiled by Johns Hopkins University. [read post]
30 Nov 2022, 4:01 am
On November 19, 2010, the Food and Drug Administration issued a drug recall, pulling propoxyphene off the shelves. [read post]
30 Nov 2022, 4:01 am
On November 19, 2010, the Food and Drug Administration issued a drug recall, pulling propoxyphene off the shelves. [read post]
30 Nov 2022, 4:01 am
On November 19, 2010, the Food and Drug Administration issued a drug recall, pulling propoxyphene off the shelves. [read post]
28 Nov 2022, 9:01 pm
Food and Drug Administration has awarded the University of Maryland’s (UMD) Joint Institute for Food Safety and Applied Nutrition (JIFSAN) with a five-year, $41 million cooperative agreement. [read post]
28 Nov 2022, 2:19 pm
An estimated 133 people were hospitalized, according to the Food and Drug Administration, which received a total of 393 reports connected to the crumbles. [read post]
23 Nov 2022, 9:03 pm
Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). [read post]
22 Nov 2022, 6:20 pm
Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. [read post]
21 Nov 2022, 4:05 am
Food and Drug Administration, (ND TX, filed 11/18/2022), alleges in part:3. [read post]
20 Nov 2022, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
17 Nov 2022, 9:05 pm
Food and Drug Administration (FDA) finalized a rule requiring food manufacturers, processors, and packers to keep detailed records of where certain foods originated and traveled. [read post]
16 Nov 2022, 9:05 pm
Food and Drug Administration, a position he assumed in December of 2018. [read post]
16 Nov 2022, 9:01 pm
It was not exactly a do-over, but a federal court did order the Food and Drug Administration to do additional analysis and reconsider its “no effect” determination from 2015 for the AquaBounty salmon. [read post]
Legal Intelligencer: Circuit Split on Materiality Standard in FCA Cases and Choosing the Right Venue
15 Nov 2022, 2:02 pm
In the Second Circuit, United States v. [read post]
10 Nov 2022, 9:05 pm
Food and Drug Administration (FDA) issued a final rule that determined spirulina extract, an extract from a type of blue-green algae, is safe for consumption. [read post]
9 Nov 2022, 10:30 am
Under FTC’s “Made in USA” Labeling Rule, a product using a U.S. origin claim is prohibited unless 1) final assembly or processing of the product occurs in the United States; 2) all significant processing that goes into the product occurs in the United States; and 3) all or virtually all ingredients or components of the products are made and sourced in the United States. [read post]
