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Pink Sheet Perspectives

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Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point

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.

Pink Sheet Perspectives User Fees Research & Development

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Japan 2010s In Review: Specialize, Focus, Innovate

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.

Japan Reimbursement

PDUFA VII: Will Gene Therapy's Rise Influence Talks?

The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.

Gene Therapy User Fees

GDUFA III: How Much Of A Fee Increase Can Industry Stomach?

Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.

Generic Drugs Review Pathway

Predicting The User Fee Reauthorization Schedule

PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.

User Fees Review Pathway

Decentralized Clinical Trials Among Topics Slated For CDER Guidance In 2020

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.

Guidance Documents Generic Drugs

Strength In Numbers: The Rise Of Cross Country Collaboration In The EU

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.

Europe Market Access

Guido Rasi - The Face Of The EMA For A Decade

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.

Europe Regulation

The Decade In Review: The UK, The EU And Brexit

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.

Europe United Kingdom

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

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).

Drug Review Drug Approval Standards
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