Pink Sheet Perspectives
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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.
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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.
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.
Countries across the EU have been joining forces over the past few years to discuss and collaborate on pharmaceutical policy issues. They are hoping among other things to secure more sustainable drug prices and get a better grasp on what new medicines are on the horizon.
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.
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).
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