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16 Aug 2012, 10:00 am by Lucas A. Ferrara, Esq.
Marqibo is marketed by Talon Therapeutics Inc., based in South San Francisco, Calif. [read post]
5 Mar 2014, 11:06 am by Cynthia Marcotte Stamer
    When carrying out these activities, most covered entities and business associates also will want to take steps to monitor potential responsibilities and exposures under other federal and state laws like the privacy and data security requirements that often apply to personal financial information, trade secrets or other sensitive data under applicable federal and state laws and judicial precedent. [read post]
28 Dec 2018, 2:22 pm by Schachtman
By calculating nested confidence intervals for the data in the Bendectin studies, Dr. [read post]
31 Oct 2009, 12:28 pm
There are also claims relating to use of Aloha Medicinals’ copyrighted website, clinical and technical data for Aloha Medicinals’ products (used by Defendants as data for their products), using Aloha Medicinals’ unregistered trademarks as metatags and Google Adwords, and intentional misrepresentation regarding broken promises over special packaging provided by Aloha Medicinals to Birkdale Medicinals. [read post]
2 Apr 2012, 10:34 am by ParkerMcDonald
  FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data. [read post]
2 Apr 2012, 10:46 am by ParkerMcDonald
  FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data. [read post]
27 Mar 2024, 10:56 am by Matt Kurnick
As summarized in the opinion, to support the FDA approval process Meril needed to “identify clinical investigators to implant the device in human subjects, collect data from those subjects, and then submit the data to the FDA. [read post]
30 Aug 2011, 1:46 pm by Brenda Fulmer
Gynemesh Prolene Soft Nonabsorbable Synthetic (Ethicon, Inc.) [read post]
30 Aug 2011, 1:46 pm by Brenda Fulmer
Gynemesh Prolene Soft Nonabsorbable Synthetic (Ethicon, Inc.) [read post]
2 Jul 2012, 3:25 am by Robert Kraft
With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market. [read post]
10 Dec 2019, 4:02 pm by Cynthia Marcotte Stamer
  The deceleration in 2018 was driven by slower growth in the use and intensity of physician and clinical services, as physician and clinical price growth accelerated in 2018. [read post]
25 Jun 2012, 11:44 am by Schachtman
Eliminating trials on the grounds that they had zero events has also been criticized for throwing away important data. [read post]
15 Sep 2009, 2:30 pm
Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine. [read post]
25 Feb 2011, 4:26 pm by M. Brandon Smith
Data in that country, he said, showed that in 2008 the ASR was failing early at a rate higher than some competing devices. [read post]