Regulatory: Page 53

Traceability/Serialization

FDA: New Supply Chain Draft Guidance

With public meetings on security and data exchange, FDA releases guidance that helps companies “define the relationship” with trading partners. The agency is soliciting comments.

August 30, 2017

Pharmaceuticals

FDA Designates Ecstasy a “Breakthrough Therapy” for PTSD

The U.S. Food and Drug Administration’s classification of MDMA as a “breakthrough therapy” could lead to faster approval.

August 28, 2017

Regulatory

No Package is an Island

Drug and device packaging consultant emphasizes the interconnectedness of packaging with other aspects of GMP and quality systems programs.

August 25, 2017