OR WAIT null SECS
September 20, 2023
Leaders at CDER and CBER give update on organizational changes at FDA.
September 19, 2023
Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.
The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.
The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.
Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.
September 18, 2023
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.
The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.
The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.
Part of the session "Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies," Sadelain discusses CAR-T cells for immunotherapy and the future of cell/gene therapies.