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31 March 2020
The US Food and Drug Administration (FDA) on Tuesday detailed a new “special emergency program” for accelerating research and development of potential treatments for coronavirus disease (COVID-19).

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31 March 2020
The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research on Tuesday said it has completed its review of Novartis’s data manipulation linked to its spinal muscular atrophy gene therapy Zolgensma (onasemnogene abeparv...
31 March 2020
As drug shortage questions and increasing demands loom amid the coronvirus pandemic, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this month added 135 medicines to its list of medicines that cannot be parallel exported from ...
31 March 2020
This “how-to” article discusses career pathways in regulatory affairs.
31 March 2020
Following an inspection last August and September, the US Food and Drug Administration (FDA) sent a warning letter to Pfizer’s injectable product manufacturing site in Visakhapatnam, India.
31 March 2020
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
31 March 2020
As COVID-19 continues to spread around the globe, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace.