Archive

Archive for the ‘Food and Drug Administration (FDA)’ Category

FDA Drug Review Deal unravels as Fiscal Cliff Looms

September 10th, 2012 No comments

A $6.4B accord for US drug and medical-device reviews is set to unravel Read more…

FDA and NIH Launch Electronic Safety Reporting Portal

May 25th, 2010 No comments

The FDA and the NIH launched a new website that, when fully developed, will provide a mechanism for the reporting of pre and post market safety data to the federal government. The new site, called the Safety Reporting Portal (SRP) will provide  access to online reporting to analyze human and animal safety related events needed to protect the public. Read more…

The Three Steps So Far, Transparency Initiative at the FDA

May 20th, 2010 No comments

Through its transparency initiative, the FDA has considered a wide range of options for increasing transparency about these and other aspects of its work. The task force (that includes senior leaders at the agency) believes that implementing some of the proposals would accelerate the development process for medical products by allowing companies to learn from the successes and failures of other products. Read more…