Research and Development Articles

Concerns about risky medicines may reduce pressure to expand drug imports while boosting demand for more comparative analyses of therapies. The growing alarm over harmful side effects related to an increasing number of popular prescription drugs is affecting critical issues for pharmaceutical manufacturers. The National Institutes of Health (NIH) recently halted important clinical trials because of fear that the ainkillers under study increased the risk of cardiovascular events. The Food and Drug Administration is on the defensive, as policymakers propose to revise how the agency evaluates pre- and postapproval drug safety data.

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Over the past month and a half, I've asked dozens of drug-manufacturing scientists and vendors, "What's the industry's most pressing issue?" The answer: "The product pipeline. It's not clear that big companies can manage innovation."Will pharmaceutical manufacturers have pharmaceuticals to manufacture? Why is it that the number of new molecular entities approved each year seems to fall, even as research budgets climb? Overall approvals have declined to 70-80 a year. That's  bout the level of  the early 90s, when the regulatory logjam prompted passage of the Prescription Drug Users Fee Act.When PDUFA provided cash to help clear the backlog, FDA produced the 1996 bumper crop of 131 approvals.

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