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2 Aug 2007, 11:44 am
PMA requires:[S]ubmission of a detailed application, including clinical data, manufacturing processes, and proposed labeling. [read post]
9 Mar 2016, 5:06 pm
To catch up on this latest guidance, Solutions Law Press, Inc. [read post]
9 Mar 2016, 5:06 pm
To catch up on this latest guidance, Solutions Law Press, Inc. [read post]
18 May 2017, 5:00 am
Setex Inc. [read post]
31 Jan 2017, 12:04 pm
Defendants also are required to preserve the data underlying any clinical studies they conduct. [read post]
3 Aug 2012, 7:52 am
From: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/CERT/Demonstrations.htmlAbout the Author: George F. [read post]
4 Feb 2022, 1:09 pm
Cardinal Health, Inc. [read post]
31 Jan 2017, 12:04 pm
Defendants also are required to preserve the data underlying any clinical studies they conduct. [read post]
21 Sep 2010, 4:05 pm
©2010 Amaxx Risk Solutions, Inc. [read post]
21 Mar 2012, 5:40 pm
Another draft guidace on “Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products” is on FDA’s guidance agenda for later this year.) [read post]
7 Feb 2023, 11:08 am
Background Invivyd is a clinical stage biotechnology company. [read post]
3 Jun 2016, 8:13 am
First is Stormans, Inc. v. [read post]
11 Sep 2023, 1:58 pm
See Record $16M Anthem HIPAA Settlement Signals Need To Tighten HIPAA Compliance & Risk Management In January, 2021, OCR announced New York health insurer, Excellus Health Plan, Inc., would pay $5.1 million to settle potential HIPAA violations related to a breach affecting over 9.3 million people. [read post]
10 Jan 2011, 4:35 pm
©2010 Amaxx Risk Solutions, Inc. [read post]
26 Feb 2009, 1:29 pm
Therefore, we need to start the cost cutting campaign by assuring the health care providers that relying on clinical data forwarded from another healthcare provider will be held by the courts as being reasonable and prudent. [read post]
10 Sep 2011, 6:40 am
Bard Inc. have to carry more clinical studies and present more safety data on the transvaginal mesh used to treat prolapsed pelvic organ, the FDA said on Friday. [read post]
12 Apr 2020, 6:03 am
She said clinical testing will start soon. [read post]
6 Dec 2018, 3:53 am
For about two years beginning in August 2014, Covidien paid a fee to hospitals and institutions that participated in a registry each time they used a new Solitaire device and reported certain clinical data about their practices for treating stroke patients to Covidien. [read post]
15 Mar 2015, 9:27 am
Cynphany Diamonds and Hearing Clinic (Niagara Falls) Inc. v. 866073 Ontario Ltd. [read post]
22 Jul 2018, 3:15 am
Philip Morris International, Inc. [read post]
