Regulators in high-income countries have a responsibility to help health authorities in low- and medium-income countries develop regulatory frameworks for cell and gene therapy products to ensure these treatments are available to all, asserts the US FDA’s biologics center’s director Peter Marks. The World Health Organization plans to soon issue a white paper proposing a harmonized regulatory framework for cell and gene therapy products, according to Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation…

Agency responds to COVID-19 pandemic’s US arrival by suspending domestic surveillance inspections and non-critical for-cause and preapproval inspections. The US Food and Drug Administration (FDA) announced a suspension of all domestic good manufacturing practice surveillance and non-critical for-cause and preapproval inspections for the duration of the COVID-19 public health crisis as part of decision to require all eligible employees to telework. The aim is to wind down all inspections by 3 April. Exceptions will be made for inspections of facilities…