Coronavirus Surveillance Expected To Rely On Existing Flu Network Without Much Strain
US CDC influenza official says that capacity is not an issue, since the system is already scaled for a pandemic, but a key will be availability of testing to distinguish the viruses.
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Real-World Evidence: CDC Prioritizing Populations, Outcomes For COVID-19 Vaccine Effectiveness Studies
Strategy for assessing how the earliest vaccines to reach market perform beyond clinical trials includes leveraging existing surveillance and data platforms, and employing a diversity of study approaches, CDC epidemiologist says; high-priority areas for study include protection against symptomatic illness among health care workers and prevention of severe disease in the elderly.
Virtual Advisory Committees Pose Technical And Practical Challenges For US FDA, Sponsors
Recent panel review of biologics center's intramural research programs had its share of technical glitches and involved agency speakers blindly presenting to committee members they could not see; the experience suggests the difficulties an industry sponsor with an application hanging in the balance may face if a virtual advisory committee were to be held.
AAM Offers Drug Manufacturing Repatriation Plan … For A Price
Under generic industry group’s proposal, the federal government would have to pay more for drugs to ensure industry investments in domestic manufacturing pay off.