Author Archives: Jill Wechsler

FDA Approves Fewer New Drugs, But Acts Fast on Innovative Products

FDA Approves Fewer New Drugs, but acts fast on innovative products As expected, the Food and Drug Administration approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near-record of 39 innovative new drugs approved in 2012. In addition, the Center for […]
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Budget Options Will Reshape Healthcare

While the struggle continues in 2014 to provide effective and affordable coverage, administration and Congressional leaders will weigh a host of spending options important to coverage and delivery. Federal outlays for healthcare and health-related federal tax benefits exceed $1 trillion a year, according to the Congressional Budget Office (CBO). These and related spending on discretionary […]
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Provider Demand to Drive Compounder Registration with FDA

The Food and Drug Administration is moving fast to implement the drug compounding provisions of new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law. But because FDA cannot compel compounders to opt for agency regulation, implementation will […]
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Where's the Vaccine for Meningitis B?

The bacterial meningitis outbreak at Princeton University in recent weeks has raised questions about why there is no vaccine in US to prevent this deadly disease, when such a therapy is approved in Europe and Australia. The current Princeton health danger prompted the Centers for Disease Control and Prevention (CDC) to request emergency import of […]
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Senate Finalizes Drug Compounding, Tracking Legislation

Congress gave final approval this week to new legislation to strengthen Food and Drug Administration authority to oversee large pharmacy compounders of sterile injectibles and to require more comprehensive tracking of prescription drugs moving through the global supply chain. The House passed the the Drug Quality and Security Act in late September, but Senate action […]
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