Pink Sheet Perspectives
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Pink Sheet infographic illustrates new drug approval trends and highlights from the past decade at the US FDA.
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Reimbursement issues continued to dominate the policy sphere in Japan during the last decade, while new forms of therapy benefited from positive regulatory reforms. Meanwhile, consolidation and specialization were major threads running through the corporate sector.
Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.
The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.
Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.
PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.
US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.
The head of the European Medicines Agency is nearing the end of his tenure. We consider Guido Rasi’s achievements over the past 10 years as well as the controversies that have arisen under his leadership – and report that sailing is likely to figure in his plans for life after the agency.
It hasn’t even happened yet, but Brexit has already had a huge impact on the EU regulatory network and on the life science sector operating in the EU, particularly in the UK. We look back at some of the key events over the past ten years that have woven the UK ever more closely into the EU’s tight-knit regulatory network, and why the UK’s future links with that network will remain uncertain after the country leaves the EU on 31 January.
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