Friday, September 26, 2014

Perspectives on Assessment, Assurance and Drug Quality: Part 2

In today's featured presentation from Biopharmaceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about Abbreviated License Pathway for biological products- which rely on “highly similar” FDA product on existing knowledge about the safety, purity, and potency of the reference product. He mentions that as of February 28, 2014, CDER had 62 requests for an initial meeting and how FDASIA makes it criminal to stay silent about counterfeiting or safety related issues.Baker states that the FDA has a focus on quality expectation for clinical performance.

Want to know more? Watch the interview here:

Watch Part 1.

Biopharmaceutical Development and Production Week will take place March 30-April 2, 2015 in Huntington Beach, California.  To get the latest updates on the 2015 program, sign up for email updates.

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