Streamlining Postapproval Submissions Using ICH Q12 & SCDM
ISPE
AUGUST 29, 2022
In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.
52 
Let's personalize your content