Home » TGA Declines Pfizer Call to Extend Window to Report Biological Safety Issues
TGA Declines Pfizer Call to Extend Window to Report Biological Safety Issues
October 13, 2017
Australia’s Therapeutic Goods Administration turned down a request from Pfizer to give it more time to report safety issues pertaining to biologicals.
In an earlier consultation document, the agency proposed a 48-hour window to report major public health threats connected to biologicals and 10 days to report serious adverse events linked to them.
Pfizer requested the same 72-hour/15-day window offered to conventional medicines.
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