Truth Seeker ID: ca1d2a Let’s create our own #OperationWarpSpeed Aug. 1, 2020, 2:10 p.m. No.4020   🗄️.is 🔗kun   >>4039

>>2089

 

https://www.fda.gov/media/97321/download

page 12

 

d. No Alternatives

 

For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the

candidate product for diagnosing, preventing, or treating the disease or condition. A potential

alternative product may be considered “unavailable” if there are insufficient supplies of the

approved alternative to fully meet the emergency need. A potential alternative product may be

considered "inadequate" if, for example, there are contraindicating data for special circumstances

or populations (e.g., children, immunocompromised individuals, or individuals with a drug

allergy), if a dosage form of an approved product is inappropriate for use in a special population

(e.g., a tablet for individuals who cannot swallow pills), or if the agent is or may be resistant to

approved and available alternative products.

 

https://twitter.com/BusyDrT/status/1289613782222696449

 

https://www.fda.gov/media/97321/download