The policy and regulatory insights advantage for biopharma decision-makers around the globe.

What's more fundamental to your business than getting products on the market, maintaining compliance to stay on the market and gaining payer coverage?

If you need to understand – and anticipate – the policy and regulatory developments critical to success in these areas, you need Pink Sheet - the world's premier source of regulatory insights that impact strategic business decisions.

Every day in biopharma involves regulatory complexity and competitive challenges. Pink Sheet arms you with forward-looking implications and the context of policies, perspectives from insiders and thought-leaders, tracking of key data to inform policy or enforcement trends, and analysis of developments throughout the industry that are particularly significant to policy-oriented readers.

GLOBAL CONTENT FROM TRUSTED EXPERTS

40+ journalists provide first-hand coverage of key events from locations around the globe. Sources and readers alike trust our coverage as independent, thorough and objective, thanks to our 80-year track record of excellence.

INSIGHT BEYOND THE HEADLINES

Pink Sheet does much more than just keep you up to date. Our staff expertise and access to decision-makers and industry leaders enable us to deliver coverage with analysis of next steps, implications and trends; and actionable insights on what developments mean for your business.

CROSSING INDUSTRY SILOS

Coverage including innovator prescription products, biosimilars, generic drugs, and OTC drugs means we uncover cross-cutting implications in these product segments, among different regulatory agencies and across traditionally separate areas – connecting up regulatory developments and business impact.

POWERFUL DIGITAL PLATFORM

New user-friendly, digital platform that is responsive to any mobile device includes a robust, boolean search and the ability to create custom, fully-responsive email alerts targeted to your specific needs.

MUST-KNOW INFORMATION

Opportunities from new approval pathways and drug development incentives programs
Emerging regulatory topics, such as biomarkers and personalized medicine
New payer requirements at both government agencies and private insurers
Regulatory agency organization and staffing, and their impact on the drug review process
Legislation affecting agency policies and budgets
Post-approval issues, including marketing restrictions and safety surveillance
Patent issues and litigation trends
Drug approvals requirements at agencies including US FDA, European Medicines Agency and China FDA, plus strategic takeaways from precedent-setting approvals

EXCLUSIVE FEATURES

FDA Performance Tracker, a data resource tracing products from US submission to approval and tracking areas of particular regulatory interest, such as drugs designated as "breakthrough" products and biosimilars
Drug Review Profiles, an in-depth “look behind” FDA approval decisions with key insights and lessons learned
Global Guidance Tracker, a monthly update of new rules and guidances with links to official documents
Special focus areas: consumer drug products and manufacturing, including QA/QC and best practices

PLUS

ASK THE ANALYST: Exclusive service where our clients can ask our expert journalists and analysts questions about any of our news stories, data and analysis when they need additional information