Posts tagged with: "fda"
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9 Oct 2023, 6:38 am
As of June 30, 2023, FDA has granted 839 breakthrough device designations. [read post]
27 Jul 2022, 9:04 pm
With these efforts, FDA hopes that the approval process for cancer treatments can be more streamlined not only for those in industry but also for FDA reviewers to meet the goals of the President’s Cancer Moonshot.The post Cancer Moonshot Lands with FDA first appeared on The Regulatory Review. [read post]
21 Apr 2015, 8:51 am
Once FDA determines whether a label change is required, FDA immediately notifies the NDA and all ANDA holders of the decision. [read post]
18 Apr 2011, 4:30 am
FDA took steps to enhance premarket device safety since GAO's 2009 report, but GAO thinks FDA hasn't done enough. [read post]
20 Dec 2013, 1:37 pm
“As required by the bipartisan FDA Food Safety Modernization Act (FSMA), the U.S. [read post]
5 Apr 2022, 3:43 pm
The post FDA Warning Letters Are Pearls Of Wisdom appeared first on Above the Law. [read post]
4 Oct 2009, 11:10 pm
Here's another of the FDA's new consumer update videos. [read post]
13 Jul 2022, 2:00 am
Muchmore (Penn State University), Marketing Authorization at the FDA: Paradigms and Alternatives, 74 Admin. [read post]
27 Sep 2023, 2:00 am
Joseph Ross Daval (PORTAL), FDA and Chevron Deference: A Case Review, 78 Food & Drug L. [read post]
24 Aug 2007, 3:46 am
The FDA has announced a new study on whether visuals in drug advertising distract consumers from understanding the risks. [read post]
7 Nov 2011, 3:20 pm
FDA prohibiting the FDA from enforcing its rules requiring new graphic labels on cigarette cartons. [read post]
6 Aug 2006, 5:02 pm
According to its press release of July 18, 2006, Organon has received FDA approval for Implanon, a new implantable contraceptive . [read post]
4 Oct 2009, 12:10 am
FDA has posted a series of videos for consumers. [read post]
5 Apr 2019, 6:32 am
Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). [read post]
29 Apr 2009, 4:41 am
FDA’s rules apply to nonsteroidal anti-inflammatory drugs, or NSAIDS. [read post]
11 Feb 2008, 7:50 am
When faced with a violation, the FDA has discretion for engaging in... [read post]
31 Jan 2009, 2:42 pm
The recent peanut salmonella scare in Georgia is in part attributed to decreasing rigor in the FDA inspection process. [read post]
16 Sep 2008, 2:44 pm
The FDA has begun posting a list of drugs being investigated for potential safety risks. [read post]
12 Sep 2008, 3:50 pm
Food and Drug Administration (FDA) today is issuing a Health Information Advisory. [read post]
29 Sep 2023, 3:32 pm
FDA states that it will also provide case studies of intramural and extramural research in the areas of nanomaterials and The post FDA Will Hold 2023 NanoDay Symposium on Continuous Manufacturing of Nanomaterials appeared first on Bergeson & Campbell, P.C.. [read post]
