Navigation Links
FDA: Tortoise, hare, or something else?

Editor's note: This is part I of a two-part column on the Food and Drug Administration approval process.

Last year, this column highlighted the debate around drug and device safety. At that time, I expected that the controversy would continue to grow.

Ind......

Full article >>> 6 congressional hearing, Waxman stated, The FDA never required the manufacturer to [conduct] a thorough post-market study of Avandia's heart risks, noting that the FDA requires such safety studies after drugs are approved.

Safety takes a back seat

As pointed out in previous columns, safety has always been a concern ever since Hippocrates laid out the dictum of First, Do N......

Full article >>> ewise, in using drugs or devices for preventive purposes, safety becomes that much more important. It's hard to justify a safety risk in the context of a condition with no symptoms.

As the Avandia story reached the front pages, a number of related side stories also appeared. One recent report ......

Full article >>> standard for drug approval is demonstrated efficacy - namely that the drug works. Safety also is a part of the process and ordinarily there are fairly extensive preclinical and animal studies designed to ferret out unsafe drugs. Most of these studies are fairly routine safety tests that simply set the backdrop to the real clinical trials that are of large enough size, or are of clever enough desig......

Full article >>>
Ogan Gurel: Abbott vs. Thailand has implications for innovation and access

Ogan Gurel: Personalized medicine and technology convergence

Of private equity, research, and drug development

<......

Full article >>>
'"/>

Source:wistechnology.com By Dr. Ogan Gurel 06/20/07


Related biology technology :

1. This FlashMob is something super
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/24/2016)... ... 24, 2016 , ... While the majority of commercial spectrophotometers and fluorometers use ... 6000i models are higher end machines that use the more unconventional z-dimension of 20mm. ... from the bottom of the cuvette holder. , FireflySci has developed several Agilent ...
(Date:6/23/2016)... , June 23, 2016 /PRNewswire/ - FACIT has ... Ontario biotechnology company, Propellon Therapeutics Inc. ... and commercialization of a portfolio of first-in-class WDR5 ... targets such as WDR5 represent an exciting class ... in precision medicine for cancer patients. Substantial advances ...
(Date:6/23/2016)... YORK , June, 23, 2016  The Biodesign ... to envision new ways to harness living systems and ... Modern Art (MoMA) in New York City ... than 130 participating students, showcased projects at MoMA,s Celeste ... Paola Antonelli , MoMA,s senior curator of architecture ...
(Date:6/23/2016)... 23, 2016 Apellis Pharmaceuticals, Inc. today ... trials of its complement C3 inhibitor, APL-2. The ... ascending dose studies designed to assess the safety, ... injection in healthy adult volunteers. Forty ... a single dose (ranging from 45 to 1,440mg) ...
Breaking Biology Technology:
(Date:3/23/2016)... Massachusetts , March 23, 2016 /PRNewswire/ ... im Interesse erhöhter Sicherheit Gesichts- und Stimmerkennung ... Xura, Inc. (NASDAQ: MESG ), ... bekannt, dass das Unternehmen mit SpeechPro zusammenarbeitet, ... aus der Finanzdienstleistungsbranche, wird die Möglichkeit angeboten, ...
(Date:3/22/2016)... Ontario , PROVO and ... Newborn Screening Ontario (NSO), which operates the ... for molecular testing, and Tute Genomics and UNIConnect, ... management technology respectively, today announced the launch of a ... next-generation sequencing (NGS) testing panel. NSO ...
(Date:3/18/2016)... 2016 --> --> ... Manned & Unmanned Vehicles, Physical infrastructure and Perimeter Surveillance & ... the border security market and the continuing migration crisis in ... Europe has led visiongain to publish this unique ... --> defence & security companies in the border ...
Breaking Biology News(10 mins):