The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone ...
FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of ...
Pharma industry in India which has a sizeable manufacture of active pharmaceutical ingredients (APIs) sees the US FDA draft guidance on Review of Drug Master Files in Advance of Certain ANDA ...
In a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which ...
The hike was made under Generic Drug User Fee Amendments of 2017 (GDUFA II). The fee in FY17 was $70,480. (Reuters) Citing high workload, the US Food and Drug Administration (USFDA) has increased fee ...
FDA has determined that NRx's Abbreviated New Drug Application (ANDA) is“substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of ...
FDA has determined that NRx's Abbreviated New Drug Application (ANDA) is "substantially complete" and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of ...
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