FDA Approvals, News & Updates

Through a structured, interactive approach designed to facilitate collaborative discussion, the MS roundtable sought to identify areas of common ground between healthcare providers (HCPs) and payers in making clinically appropriate, value-based patient management decisions. HCPs and payers represented on the panel discussed their responsibilities, goals, and challenges in an open forum that encouraged the candid exchange of ideas.

The treatment of multiple sclerosis (MS) involves pharmacotherapy to treat disease progression, symptoms, and acute exacerbations. Patients may also engage in a number of nonpharmacologic interventions, such as physical and occupational therapy.

Prominent Cardiologist Hammers the FDA: Insufficient Funding Compromises the Science of Drug Approvals

There is a hunger for reform of the US Food and Drug Administration (FDA). To a great extent, that hunger is fueled by the prevailing sentiment in today's regulatory atmosphere—a drive to make our environment as risk free as possible when it comes to medical treatment.

Late in 2007, the U.S. Food and Drug Administration (FDA) held a public meeting chaired by Dr. Randall Lutter, Deputy Commissioner for Policy, and Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research, to discern the prevailing thought on the possibility of developing a behind-the-counter (BTC) status for drug access in the United States. Similar to over-the-counter (OTC) status, BTC would allow a patient to access medications at the pharmacy without seeing a doctor.

Even the most casual observer of the pharmaceutical and biotechnology industries will have noticed that in 2007, the U.S. Food and Drug Administration (FDA) issued an overwhelming number of approvable letters and a corresponding underwhelming number of approval letters for new product applications. In fact, according to a recent publication by Sagient Research, the number of approvals fell by 13% from 2006, while the number of approvable letters increased by 40%.

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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