Articles

Leaders at CDER and CBER give update on organizational changes at FDA.

Staying Compliant in 2023

Videos

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

Feliza Mirasol is the science editor for 

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.

Pharma Award Finalists for CPHI Barcelona Have Been Announced

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

EMA Prepares for Regulation on Health Technology Assessment

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.

The Impact of Advanced Manufacturing Technology (PDA/FDA Joint Regulatory Conference 2023)

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference. 

Being Innovative in CGMP Training While Adapting to Change 

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.

Barriers to the Development of Continuous Manufacturing and ICH Q13 (PDA/FDA Joint Regulatory Conference 2023)

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public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.

FDA Issues Guidance on Biosimilar Labeling

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.

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