Topic: Center For Devices And Radiological Health
Pressure to spur development of new medical products, deal with an increasingly global pharmaceutical supply chain, and accomplish more tasks with...
Posted on 09/27/11 at 6:10pm by Webmaster . Medical Records Active Archive™ Data Storage Solution Registered by FDA Center for Devices and...
The chief U.S. medical device regulator did not tell Congress that rejecting Mela Sciences'(MELA) skin cancer detection device was a mistake...
With Alexza Pharmaceuticals (ALXA) expected to refile its AZ-004 for the rapid treatment of agitation in schizophrenia or bipolar disorder patients...
We are upgrading our rating on shares of Alexza Pharmaceuticals (ALXA) to "Outperform" and raising our price target to $3 per share. We believe the...
U.S. FDA Headquarters' Center for Devices and Radiological Health Achieves LEED Gold Certification . . Tishman Construction Provides Vital...
On October 10, 2010, the U.S. FDA issued a complete response letter (CRL) on the approval of AZ-004 (Staccato loxapine) for the rapid treatment of...
Eli Lilly (LLY) said that its global phase 3 trial evaluating Alimta (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck failed to meet its primary endpoint for overall survival ...
A little over a year ago, we wrote about several independent, grassroots forces that were agitating for more stringent Food and Drug Administration oversight in the medical device industry. In the past, device manufacturers have aimed to roll their new products out ...
MO, Oct. 11 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato loxapine), submitted ...
Video Gallery
-
Question 4 - Live Telecast - Jeffrey Shuren ...
Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological ...2011-11-12 -
Live Telecast Intro Part 1 - Jeffrey ...
Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological ...2011-11-13 -
Question 5 - Live Telecast - Jeffrey Shuren ...
Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological ...2011-11-12
