Posts tagged with: "fda"
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23 Aug 2019, 7:18 am
This information collection supports the review program under the Prescription Drug User Fee Act (PDUFA), which allows FDA to collect user fees for the review of human drug and biologics applications for fiscal years 2013 through 2021. [read post]
4 Jan 2013, 7:35 am
Food and Drug Administration.The FDA sent out warning letters in December to more than 350 medical practices alerting them of danger, the Associated Press said. [read post]
23 Nov 2018, 7:55 pm
The post FDA Links Recent Romaine Lettuce Recall to California appeared first on Legal Reader. [read post]
20 Jan 2014, 1:03 pm
Last week the FDA issued a draft guidance on the use of social media in connection with the sale and distribution of drugs and biologics. [read post]
28 Nov 2022, 9:07 pm
Food and Drug Administration (FDA) announced its approval of Eli Lilly's Rezvoglar (insulin glargine-aglr) product as an interchangeable biosimilar to Sanofi's Lantus (insulin glargine). [read post]
16 Dec 2016, 12:55 pm
” First, while Apotex said that “representations commensurate with information in an FDA label generally” (emphasis added) wouldn’t be actionable under the Lanham Act, it went on to acknowledge (in a footnote) that “Lanham Act liability might arise if an advertisement us[ing] information contained in an FDA-approved label... [read post]
17 Jun 2008, 9:54 am
I read in the Wall Street Journal today, that the FDA said it will add warnings to the labels of older anti-psychotic drugs, regarding dangers of drug use for persons with dementia.These meds haven't been FDA approved for folks with dementia, but were being prescribed by physicians all over the country. [read post]
2 Apr 2020, 8:27 am
The House Committee had previously contacted the FDA in the summer of 2019 urging the ban of e-cigarettes. [read post]
14 Jul 2022, 6:47 am
Fox Business reports, “The FDA is cautioning consumers this week after sending warning letters to four US companies that produce honey-based products containing prescription drugs for sexual enhancement. [read post]
9 Feb 2012, 11:50 am
FDA Warning Letter to Animas “Unless [Animas] corrects violations soon, it could face fines and other disciplinary sanctions…” FDA warning letter. [read post]
18 Sep 2007, 11:43 pm
"Alas, the FDA gives P and G 15 working days to take steps to take action, or more as needed. [read post]
24 Mar 2009, 12:30 am
Under FDA rules adopted in 2006 (FDA's Q&A), women 18 and over may obtain the drug without a prescription, but only upon showing identification to a pharmacist. [read post]
22 Jun 2010, 8:38 am
The original FDA safety advisory can be found here. [read post]
17 Jun 2023, 1:25 pm
Perhaps not as far as I would have gone – “Get the F out of the FDA” – but a major step in the right direction to elevate Food Safety and Human Nutrition at the FDA. [read post]
17 Apr 2024, 11:30 am
Here is the latest from the FDA on active investigations: [read post]
16 Nov 2017, 8:10 pm
The FDA invites public comment on the draft guidelines through January 8, 2018. [read post]
26 Jul 2018, 11:29 am
FDA Commissioner Dr. [read post]
26 Jul 2018, 11:29 am
FDA Commissioner Dr. [read post]
13 Jun 2024, 10:33 am
FDA concurred with all nine of our recommendations. [read post]
4 Jun 2007, 10:40 pm
The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. [read post]
