Articles Tagged With: expanded
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New FDA Guidance Explains COVID-19 Expanded Access Policy
The Food and Drug Administration published an eight-page guidance for IRBs handling expanded access to investigational products during the pandemic. The guidance, issued in June, explains how IRBs might review individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency.
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FDA Move Widens Approved Use of Human Papillomavirus Vaccine
The Food and Drug Administration has approved the use of the nine-valent human papillomavirus (HPV) vaccine in women and men ages 27-45. The Advisory Committee on Immunization Practices (ACIP) is scheduled to review further information at its February 2019 meeting, with a potential vote at that time. Insurance reimbursement often is based on ACIP guidance.