FDA > Emergency Use Authorization

FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.

Health Canada > Explanatory note for the Covid-19 Interim Order

New safety concerns identified for 1 in 3 FDA-approved drugs

Kim Iversen: BIG PHARMA’S Ties To The FDA Should Be Questioned

Over a quarter of all FDA approved drugs later — sometimes years later — are taken off the market because they find out they’re actually not so safe or they discover serious side effects that require a large, black box warning warning to be applied on the packaging.