House eyes FDA technology and resources
Executive Summary
Even before the fiscal year 2009 budget is proposed, the House Energy and Commerce Oversight Subcommittee is beginning to assess FDA resources. A November report from an FDA Science Board subcommittee decries weaknesses in the agency's regulatory science and inadequate scientific expertise. FDA Commissioner Andrew von Eschenbach, General Accounting Office officials and Science Board members are among those scheduled to testify at the Jan. 29 hearing to address the report, which claims resources are key to reversing FDA's scientific decline (1"The Pink Sheet" Dec. 10, 2007, p. 15)...
You may also be interested in...
What Does AERS Mean? FDA Takes A Close Look At Spontaneous Reporting
Amid a flurry of recent drug safety initiatives, FDA is not losing sight of the importance of spontaneous adverse event reporting. In fact, the agency is taking steps to evaluate and improve its passive surveillance system, which it expects to remain the cornerstone of its drug safety oversight
FDA Should Look Through IIRIS To Improve Science, Panel Says; Funding Is Worry
Increasing developments in emerging sciences, such as personalized medicine, could reach roadblocks at FDA where limited resources for specialized personnel and advanced equipment may inhibit research, a report from FDA's Science Board's Subcommittee on Science and Technology shows
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.