Drug Development Tools: Passed And Future
FDA has qualified a total of eight biomarkers submitted by two different consortia through a process that has followed, to varying degrees, the route described in the recently released draft guidance on drug development tool qualification.
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The firms that obtained FDA/EMEA qualification of seven nephrotoxicity biomarkers for preclinical drug testing are midway through development of a protocol to test their efficacy in a clinical trial
Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.
‘Frontline’ Essential Workers, Persons 75 Years And Older Prioritized For Second Phase Of COVID Vaccination
Essential workers who cannot work remotely and have high levels of interaction with the public, and individuals ≥75 years old, should get vaccinated ahead of those 65-74 years old and those with comorbid conditions, CDC Advisory Committee on Immunization Practices recommends.