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From Our Perspective

Insights from CDER leadership and experts on public health actions

CDER collaborates with global regulators on pharmaceutical quality assessments and inspections

By: Theresa Mullin, Ph.D., CDER’s Associate Center Director for Strategic Initiatives, and Michael Kopcha, Ph.D., R.Ph., director of CDER’s Office of Pharmaceutical Quality

FDA and the European Medicines Agency (EMA) recently completed the first collaborative assessment of a proposed post-approval change for a critical oncology biologic with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) serving as an observer. The work, in which FDA and EMA reviewed and approved a proposal to add new manufacturing and quality control sites, can help assure the supply of the medicine.

More with Theresa Mullin, Ph.D. and Michael Kopcha, Ph.D., R.Ph.


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