General Information

FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates

The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) […]

eCTD submission

Common Repository Centralised Procedure submissions

The following National Competent Authorities such as Estonia, Iceland, Liechtenstein, Slovenia are now ready to receive Centralised Procedure submissions via the Common Repository only means no longer accept Centralised Procedure submissions on CD or DVD or via CESP. This will apply to all types of Centralised Procedure eCTD procedures, including ASMF submissions related to centrally […]