In the News

This past April has seen nothing less than a tug of war between Congress and the US Food and Drug Administration (FDA). During April and May, FDA staffers have been on Capitol Hill to offer testimony to Congress no less than 10 times. During the entire duration of 2006, the FDA only offered 12 testimonies. Congressional scrutiny of the agency has obviously increased in the past 2 years.

On August 11, 2008, the Centers for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) officially changed the way the division is responding to new drug applications (NDAs), raising mild alarm in some circles by stating that in the future, rather than respond with "approvable" letters or "not approvable" letters, the division would be responding with "complete response" letters.

Talk is swirling around Washington as to who may replace Dr Andrew C. von Eschenbach at the helm of the US Food and Drug Administration (FDA). One well-known blogger has even begun a voting contest where readers can choose from several candidates for FDA Commissioner and cast a vote. There is little question that the policy environment is pregnant with change, but in most cases, it is quite possibly less important who is appointed rather than what the changes may entail.

In early September, the US Food and Drug Administration (FDA) sent out a press release posting the first quarterly report titled "Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)," listing the potential safety issues of drugs currently on the market. This action is in conformance with direction provided by Congress in accordance with Title IX, Section 921, of the Food and Drug Administration Amendments Act of 20071 (see Sidebar).

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