Posts tagged with: "fda"
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4 Oct 2021, 3:18 pm
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. [read post]
12 Sep 2023, 1:40 pm
FDA officials will consider whether to ban this drug outright, Here is the article https://www.nytimes.com/2023/09/12/health/cold-medicine-decongestant-fda.html? [read post]
16 Sep 2007, 10:19 pm
The article first analyzes the FDA's justifications for reversing its long-held views to the contrary and explains why the FDA's position cannot be reconciled with its governing statute. [read post]
1 Feb 2019, 9:00 am
FDA Legal Trap # 1: FDA Looks to Intended Use, Giving FDA Broad Enforcement Discretion The intended use doctrine gives FDA a trump card over enforcement activity. [read post]
10 Feb 2012, 9:09 am
In a recent letter to the FDA, the Project on Government Oversight claimed that four of the 26 advisors on the FDA panel had research and financial ties to the drug companies that make Yaz, Yasmin, and their generic counterparts. [read post]
16 Jan 2014, 7:44 am
” The report directed patients who take Gilenya and develop problems to the FDA’s MedWatch program. [read post]
20 Apr 2015, 7:44 am
An FDA advisory panel meeting last month called for more data to evaluate safety risks. [read post]
22 Dec 2023, 11:25 am
As the FDA explains, this is “more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children. [read post]
22 Dec 2023, 11:25 am
As the FDA explains, this is “more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children. [read post]
22 Dec 2023, 11:25 am
As the FDA explains, this is “more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children. [read post]
23 Aug 2021, 5:26 am
The FDA sampled 26 products it bought on Amazon. [read post]
13 Jul 2010, 9:06 am
In fact, days ago an FDA physician and a leader in the FDA's cardiovascular division, Dr. [read post]
13 Jul 2010, 9:06 am
In fact, days ago an FDA physician and a leader in the FDA's cardiovascular division, Dr. [read post]
21 Nov 2010, 9:20 pm
By James DeGiulio -- Earlier this month, we reported that a major issue discussed at the Food and Drug Administration's public hearings on the implementation of the Biologics Price Competition and Innovation Act (BPCIA) concerned the standards that the FDA will require for clinical testing of biosimilars (see "Clinical Trial Requirements Are Top Issue at FDA Hearings on Biosimilars"). [read post]
18 Oct 2007, 10:33 pm
Ignoring the FDA's resolution of this issue, plaintiffs alleged in state-law litigation that warnings the FDA had prohibited were mandated by state tort law. [read post]
13 Jul 2010, 1:59 pm
Following are links to news stories and opinion of the first day of a FDA advisory panel meeting on the diabetes drug Avandia. [read post]
17 May 2022, 8:15 am
In light of that and the conclusion of the FDA investigation, the Department of Justice Monday filed a consent decree with Abbott in the Western District of Michigan on behalf of the FDA. [read post]
18 May 2020, 4:47 pm
According to the official FDA press release, the FDA sent warning letters to Allergan and Ideal Implant Incorporated. [read post]
13 Jun 2011, 9:14 am
When that food became significantly rodent-invested, the FDA proceeded with criminal charges. [read post]
15 Apr 2012, 9:30 pm
The FDA indicated its willingness to take regulatory action in the future if it were to determine that BPA exposure poses health risks. [read post]
