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:10/10/2017)... ... October 10, 2017 , ... For the second ... a US2020 STEM Mentoring Award. Representatives of the FirstHand program travelled to Washington, ... from US2020. , US2020’s mission is to change the trajectory of STEM education ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... 13 prestigious awards honoring scientists who have made outstanding contributions ... scheduled symposium during Pittcon 2018, the world’s leading conference and exposition for laboratory ...
(Date:10/9/2017)... ... October 09, 2017 , ... ... in the medical journal, Epilepsia, Brain Sentinel’s SPEAC® System which uses the ... in detecting generalized tonic-clonic seizures (GTCS) using surface electromyography (sEMG). The prospective ...
(Date:10/6/2017)... ... October 06, 2017 , ... On Tuesday, October ... on INSIGhT, the first-ever adaptive clinical trial for glioblastoma (GBM). The featured speaker ... is free and open to the public, but registration is required. , WHAT: ...
Breaking Biology Technology:
(Date:4/24/2017)... 2017 Janice Kephart , former ... Strategy Partners, LLP (IdSP) , today issues the ... Trump,s March 6, 2017 Executive Order: Protecting ... can be instilled with greater confidence, enabling the ... refugee applications are suspended by until at least ...
(Date:4/13/2017)... UBM,s Advanced Design and Manufacturing event in ... and evolving technology through its 3D Printing and Smart ... the expo portion of the event and feature a ... on trending topics within 3D printing and smart manufacturing. ... will take place June 13-15, 2017 at the Jacob K. ...
(Date:4/11/2017)... BROOKLYN, N.Y. , April 11, 2017 /PRNewswire-USNewswire/ ... identical fingerprints, but researchers at the New York ... University College of Engineering have found that partial ... fingerprint-based security systems used in mobile phones and ... previously thought. The vulnerability lies in ...
Breaking Biology News(10 mins):