Revance Therapeutics Inc (RVNC)

[floblu14]

Not jumping the gun nor reading between the lines - ME THINKS the FDA inspection is a fait accompli - therefore approval is forthcoming.

Select rationale:

New Career Opportunity listed -

Sr. Director, Engineering, Facilities and EH&S

This is a lead role for the Facilities engineering and operation of a state-of-the-art cGMP biopharmaceutical manufacturing facility located in Newark CA.

https://www.revance.com/careers/job-listings/?p=job%2Fomswefwi

U.S. FDA Rules & Regulations -

FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The approval process for new and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMPs. FDA assessors and investigators determine whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market.

https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations