Posts tagged with: "fda"
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21 Dec 2021, 6:06 am
” From the news release of the American Association for Justice.The post FDA Faces Dilemma as Menthol Cigarette Ban is Hit with Lawsuits first appeared on Kraft Elder Law. [read post]
5 Nov 2008, 11:04 am
The FDA might accomplish this by imbedding intellectual property management within the FDA’s regulatory scheme. [read post]
14 Jun 2011, 5:40 am
Or if FDA is requiring an overly burdensome clinical study? [read post]
22 Jul 2011, 6:48 am
In the case of mobile apps, some of those, too, will require FDA scrutiny. [read post]
1 Mar 2012, 7:46 am
Dickinson as FDA’s Chief Counsel. [read post]
25 Oct 2017, 2:57 pm
Food and Drug Administration (FDA), in coordination with the U.S. [read post]
9 Mar 2015, 11:03 am
Note that while the document is issued by FDA and is drafted as guidance that would apply to FDA-regulated clinical investigations, the HHS Office for Human Research Protections (OHRP) is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations, 45 CFR part 46, and to issue a joint OHRP and FDA guidance document on this topic when the final guidance document is… [read post]
7 Sep 2022, 9:06 pm
Robert Califf, Commissioner of Food and Drugs at FDA. [read post]
15 Oct 2012, 1:34 pm
”The FDA says only Frosted Mini-Wheats Bite Size Original and Mini-Wheats Unfrosted Bite Size with the letters KB, AP or FK before or after the expiration date have the potential to contain the metal fragments.http://boston.cbslocal.com/2012/10/10/fda-recalls-certain-mini-wheat-cereals-after-metal-fragments-found/ [read post]
5 Jul 2018, 12:07 pm
FDA Finds 15 Confirmed Cases of B. cepacia Complex The FDA first learned of this latest B. cepacia outbreak on March 16, 2018, when they were alerted to two clusters of the infection in several states. [read post]
5 Oct 2021, 1:18 pm
McKinsey has consulted for the FDA and opioid drug companies simultaneously for years without reporting any conflicts of interest. [read post]
4 May 2024, 9:05 pm
Use link above to go to FDA page with links to specific alerts. [read post]
23 Apr 2012, 9:59 pm
Food and Drug Administration on April 2, Abbott Laboratories requested that the FDA refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act (BPCIA) that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA prior to March 23, 2010. [read post]
2 Oct 2023, 9:02 pm
Use link above to go to FDA page with links to specific alerts. [read post]
19 Jul 2022, 1:12 pm
FDA Commissioner Dr. [read post]
8 Aug 2006, 10:10 pm
Hillary Clinton and other Senate Dems, who had vowed to delay a vote on the nomination until the FDA cleared its apparently unprecedented derailing of the OTC application. [read post]
16 Jul 2010, 1:57 pm
The study cited by the FDA was conducted by a team of researchers, led by Dr. [read post]
30 Sep 2010, 8:56 am
The FDA has contacted every manufacturer of the sleep positioners and asked them to stop selling their products. [read post]
30 Sep 2010, 8:56 am
The FDA has contacted every manufacturer of the sleep positioners and asked them to stop selling their products. [read post]
21 Oct 2011, 9:10 am
Congress is currently pressuring the FDA to change or do away with the 510(k) system. [read post]