CDER Reorganization Chart June 2011

Poor API quality may often lead to delays in production and a shortage of supply.

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

Scientific, economic, and practical factors should be considered when choosing between the frozen state and lyophilization.

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

An article describing the technological advancement from one process controller to the new one.

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.