FDA GDUFA Testimony Presentation Slides

The commitment will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple states.

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.

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

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.

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.

The new United Kingdom-based firm has sites located in France, Spain, and Sweden, thanks to an acquisition of Synerlab Group and several Recipharm facilities in 2024.