Brief: Arch Therapeutics Withdraws 510(K) With Plans To Resubmit After Further Discussions With FDA
18/12/2017 12:50
Dec 18 (Reuters) - Arch Therapeutics Inc ARTH.PK :
* ARCH THERAPEUTICS WITHDRAWS 510(K) WITH PLANS TO RESUBMIT
AFTER
FURTHER DISCUSSIONS WITH FDA
* ARCH THERAPEUTICS INC - PLANS TO SUBMIT A NEW 510(K) AS
SOON AS
POSSIBLE FOLLOWING FURTHER DISCUSSION WITH FDA FOR AC5 TOPICAL
GEL
* ARCH THERAPEUTICS- WITHDREW APPLICATION AFTER GETTING FDA
QUESTIONS FOR WHICH ADEQUATELY COMPREHENSIVE RESPONSE COULD NOT
BE PROVIDED IN REVIEW PERIOD
* ARCH THERAPEUTICS - FDA REQUESTED ADDITIONAL INFORMATION
FOR
AC5 TOPICAL GEL THAT WAS NOT FEASIBLE TO PROVIDE WITHIN MANDATED
MDUFA DEADLINES
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Brief: Arch Therapeutics Withdraws 510(K) With Plans To Resubmit After Further Discussions With FDA