Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for ...

The US Food and Drug Administration (FDA) has released revised and final versions of four documents intended to facilitate the submission of drug applications using the electronic common technical ...

The Final Q-Sub Guidance provides comprehensive guidance on the Q-Sub process and finalizes the draft guidance regarding the Q-Sub program that was issued on March 15, 2024, with minimal changes from ...

The Food and Drug Administration’s science-based mission includes receiving, generating and reviewing a wealth of data and products from the vast array of manufacturers and firms that the agency ...