Brief: Aziyo Biologics Provides Update On FDA Submission For Cangaroo® RM Antibacterial Envelope

Elutia

20/03/2023 12:42

March 20 (Reuters) - Aziyo Biologics Inc  AZYO.O :
    * AZIYO BIOLOGICS PROVIDES UPDATE ON FDA SUBMISSION FOR
CANGAROO® RM ANTIBACTERIAL ENVELOPE
    * AZIYO BIOLOGICS INC - ON MARCH 16, 2023, COMPANY RECEIVED
A NOT
SUBSTANTIALLY EQUIVALENT DETERMINATION FROM FDA
    * AZIYO BIOLOGICS INC - NOTICE DEFINED OUTSTANDING ITEMS
THAT NEED
TO BE ADDRESSED IN ORDER TO OBTAIN MARKET CLEARANCE
    * AZIYO BIOLOGICS - ITEMS RELATE TO DRUG TESTING, PRIMARILY
REQUEST BY FDA TO MODIFY AN IN VITRO DRUG RELEASE ASSAY EMPLOYED
AS MANUFACTURING CONTROL
    * AZIYO BIOLOGICS INC - COMPANY DOES NOT EXPECT TO APPEAL
DECISION
    * AZIYO BIOLOGICS INC - BELIEVES MOST EXPEDITIOUS PATH
FORWARD IS
TO WORK WITH FDA TO PROVIDE ADDITIONAL DATA REQUESTED

Source text for Eikon:  ID:nGNX4GPwyM 
Further company coverage:  AZYO.O 

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