2016, FDA and Method Validation - Pharmacy Technician Pulse

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2016

FDA

Method Validation

CMC Requirements for New Drug Registration in Latin America

ISPE

MAY 9, 2023

Although ANVISA has been an ICH member since 2016, the implementation plan of ICH guidelines is still ongoing. 21 Similarly, the FDA Center for Drug Evaluation and Research (CDER) began issuing electronic CPPs (eCPP) starting December 2021. Published 29 February 2016. Modernization of the FDA CDER Export Certificate Program.”

Documentation

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies

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.

Documentation

Documentation FDA Communication Packaging

CMC Requirements for New Drug Registration in Latin America

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

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