AustralianTherapeutic Goods Administration (TGA) Australian

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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