Category Archives: Health

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As Vaccine Exemptions Rise, Risk of Outbreaks Intensifies

herd-immunity

Generally, we think of vaccines as protecting the vaccinated. We often forget that vaccines, when administered to enough people, protect those in the community who cannot be vaccinated due to certain health conditions, who are too young to be vaccinated, or who experience vaccine failure. This “herd immunity,” as it’s called, is analogous to the concept of ‘safety in numbers’ and is critical to outbreak prevention. However, as reported by Valerie Bauerlein and Betsy McKay Read More >

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What Parallel Review Means for Manufacturers

Drug Manufacturing

By Stephen Rothenberg, J.D. and Matt Levy, J.D., Numerof & Associates, Inc. (NAI) Currently, the FDA and CMS consider new medical products in series; after FDA approval or clearance, CMS begins consideration of a National Coverage Determination (NCD), if requested by an interested stakeholder. Any party seeking drug approval (e.g., manufacturers, suppliers, providers, medical professional organizations, and Medicare beneficiaries) may initiate a request for an NCD. In addition, CMS may initiate a request for an Read More >

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Importance of Reauthorizing Pandemic All-Hazards Preparedness Act

Sen. Casey

Senator Robert P. Casey, Jr. (D-PA) joined with BIO and The Center for Biosecurity of UPMC to co-sponsor a Hill briefing on the reauthorization of the Pandemic All-Hazards Preparedness Act (PAHPA) on March 1st.  Officials from the Food and Drug Administration, Centers for Disease Control and Prevention, the White House, and Department of Health and Human Services as well as experts from the Center for Biosecurity at UPMC and the WMD Center discussed the critical Read More >

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International Rare Disease Day: Join the Movement

Nicole Boice

By Nicole Boice, President and Founder, RARE Project Being diagnosed with any illness can be overwhelming. Imagine what it’s like, though, to be diagnosed with a disease that you’ve never heard of – maybe even one that your doctor has never seen before. Millions of people start this diagnostic odyssey on their own, with little or no support, no real direction, with feelings of isolation and fear. That’s exactly the situation in which millions of Read More >

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Let’s Get PDUFA V Approved, Fast

Marc Boutin

By Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council At this time of the year, it can be helpful to reflect on the past to guide us in the future. I was recently reading an editorial about the National Health Council (NHC) printed in January 1957 – 37 years after the organization’s creation. It spoke about the need for action with “an unprecedented degree of cooperation among health agencies and Read More >

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