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  • Regulatory NewsRegulatory News

    How the Government Will Pay Companies to Develop Biodefense Products and Win Lucrative PRVs

    As the nearly 1,000-page 21st Century Cures Act is implemented in phases, the full impact of the law is just beginning to be realized, and for one provision, the law has created a new program that rewards companies for developing products that the government purchases and often pays to develop. Background Under section 3086 of the Cures Act , the US Food and Drug Administration (FDA) must establish a new priority review voucher (PRV) program for material th...
  • Regulatory NewsRegulatory News

    Congress Considers Priority Review Vouchers for Medical Countermeasures

    Members of the House Energy and Commerce Oversight and Investigations subcommittee were briefed on recommendations at a hearing Friday for improving the nation's biodefence strategy against natural and man-made threats. The recommendations are particularly timely as legislators and public health officials scramble to mount a response to the Zika virus outbreak across Latin America and the Caribbean. Many of these recommendations come from the Blue Ribbon Study Panel on ...
  • Regulatory NewsRegulatory News

    As Ebola Catches Attention of Congress, FDA Emergency Preparedness Bill Becomes Campaign Fodder

    In March 2013, US President Barack Obama quietly signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) , a biodefense bill which gave the US Food and Drug Administration (FDA) new authority to preemptively prepare for potential pandemics or biological threats. But while the bill received little attention and even less congressional opposition at the time, an outbreak of Ebola in West Africa is now making the bill's passage—and FDA's ...
  • After Flu Concerns, Regulators Look to Issue Guidelines on 'Dual Use' Preclinical Studies

    International healthcare bodies are looking to issue guidelines on 'dual use' research on potentially hazardous materials and diseases after a researcher sent shockwaves through the medical community in 2012 for his re-engineering research on a potentially deadly strain of bird flu, reports The Financial Times. "Washington has just issued new guidelines; the Royal Society, the British scientific organization, rushed to convene a high-level session last week on the topi...