Drug Review

Official: Delays in Drug-approval Process Could be Deadly

A European official states a new system for approving proposed drugs is tied in bureaucratic knots and ultimately could harm patients.

The system for approving new drugs for use on the NHS in Scotland is bureaucratic, deeply flawed and could cost lives, according to a Labour MSP.

Dr Richard Simpson, a former doctor, said his constituents are confused by the process and it had created a postcode lottery. He was speaking as an investigation into access to expensive, potentially life-saving medicines opened in the Scottish Parliament. Scotland has repeatedly been criticised for preventing new, costly drugs from being prescribed by the NHS, when the same treatments are available south of the Border. 

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Report: FDA Drug Approvals to Decline in 2012

Market research from Fitch Ratings indicates the FDA will approve fewer novel drugs in 2012 compared to 2011.

Fitch Ratings expects the Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 as compared to 2011 while the industry faces several ongoing operational risks, according to a new report.

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FDA Approves Weight-management Drug Qsymia

The drug, from Vivus Inc., is intended for use in adults with a BMI of 30 or greater, or overweight individuals with at least one weight-related condition.

The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management.

The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

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Advisory Committee Recommends Against Xarelto Approval

An FDA advisory committee recommended against the oral anticoagulant, which is intended to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.

Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS) in combination with standard antiplatelet therapy.

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GAO Critical of FDA's Drug Review Process

Leaders with the Government Accounting Office hold that the agency needs to be more efficient and effective in processing applications.

While a new report from the Government Accountability Office (GAO) shows that the Food and Drug Administration (FDA) has become more efficient in terms of its overall processing and reviewing applications, it also found that three of the five consumer advocacy group stakeholders that GAO researchers spoke with raised issues about whether FDA is adequately ensuring the safety and efficacy of the drugs it approves for marketing.

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