Posts tagged with: "fda"
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15 May 2008, 6:00 am
Although the Commissioner acknowledged earlier in the year that the FDA was not able to meet its responsibilities and an FDA Science Panel reported last year on the agency's failings, the budget requested by the Bush Administration was insufficient to cover even payroll increases. [read post]
16 Oct 2023, 9:06 pm
That expertise and authority rests with the FDA alone. [read post]
25 Oct 2007, 7:17 am
Here, however, the brochure's claims about FDA approval are "reasonably clear" and there is no need to leave the matter to the FDA. [read post]
13 Mar 2019, 10:09 am
In a statement announcing the new regulations, FDA Commissioner Dr. [read post]
25 Sep 2016, 8:06 pm
This marks the fourth biosimilar approved by the FDA pursuant to the BPCIA. [read post]
26 Nov 2013, 9:10 pm
§ 321(h) as a "medical device" (see "FDA Threatens... [read post]
5 Sep 2023, 9:00 am
This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. [read post]
17 Apr 2015, 8:06 am
According to an FDA blog post, the goals of the FDA/CMS task force include: identifying areas of similarity between the FDA quality system regulation and requirements under the Clinical Laboratory Improvement Amendments (CLIA); working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and leveraging joint resources to avoid duplication and maximize efficiencies. [read post]
27 Apr 2009, 5:31 am
The full FDA and CDC press release can be found here. [read post]
24 Jun 2014, 7:09 am
Read more: FDA moves for more warnings on testosterone products - FiercePharma http://www.fiercepharma.com/story/fda-moves-more-warnings-testosterone-products/2014-06-20#ixzz35Z6yNsJM Subscribe at FiercePharma [read post]
29 Apr 2014, 11:49 am
From the FDA: The U.S. [read post]
29 Jan 2019, 9:53 am
FDA Restrictions Come in Wake of Vaping Epidemic Given grave concerns about the high levels of teen e-cig use, the FDA proposed limitations on the sale of e-cigarettes. [read post]
20 Nov 2018, 6:38 am
A transition from FDA to USDA oversight will occur during the cell harvest stage. [read post]
16 Dec 2021, 6:35 pm
Under FDA regulations, healthcare providers must provide patients with information on the pill. [read post]
2 May 2009, 2:16 am
FDA also encourages you to report the problems to FDA’s MedWatch Adverse Event Reporting progam: www.fda.gov/MedWatch/report.htm. [read post]
23 Feb 2021, 6:13 am
FDA takes issue with Dsuvia marketing. [read post]
8 Jul 2020, 1:12 pm
The US Court of Appeals for the DC Circuit overturned a US Food and Drug Administration (FDA) rule on tobacco warnings on Tuesday, holding that the FDA did not adequately consider whether its regulation would have an impact on the number of smokers. [read post]
27 Sep 2011, 3:58 am
This follows earlier reports from the FDA that users of these pills suffer more potentially fatal blood clots than users of other available birth control pills. [read post]
21 Feb 2007, 10:01 pm
The asthma drug Xolair should carry the strongest warning possible-- a black box warning - about a reaction known as anaphylaxis, according to the FDA. [read post]
13 Jul 2008, 10:52 am
The FDA considers this new analysis to be "new safety information" as defined in FDAAA.Link here. [read post]
