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The Prescription Drug User Fee Amendments of 2002 amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning definitions and the authority to assess and use drug fees. It provides public accountability for goals in the process for the review of human drug applications.
The CDC uses a number of tools to monitor the safety of vaccines. The Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program run by CDC and the FDA. "VAERS detects possible safety issues with U.S. vaccines by collecting information about adverse events (possible side effects or health problems) after ...
The group's report was titled A National Blueprint for Biodefense. [12] The report described many biological threats, including those posed by the Islamic State and Al Qaeda, as well as nation states, and "mishandling of lethal biological agents by the U.S. government," as reasons for making biodefense a high national priority. [9]
"Because we're in this public health emergency, we've gotten way more data on the COVID vaccine than we have on most vaccines that go through the full approval process," said former FDA chief Mark ...
The CDC’s new director is traveling the country, meeting with state leaders and using social media to win back the public’s trust. The CDC wants your trust back: It’ll ‘take time to ...
Along with Biomedical Advanced Research and Development Authority (BARDA), it includes internal HHS partners at the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC), along with external inter-agency partners at the Department of Defense (DoD), the United States ...
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1]
The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases.