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Review Pathways

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Latest From Review Pathway

Expanded Access Data Can Support Approval Decisions, US FDA Says

Formal reg not needed, according to agency; officials agree that regulatory flexibility is best way to offer sponsors advice, saying data collected during compassionate use can be helpful in guiding regulatory decisions. 
Clinical Trials Review Pathway

Keeping Track Of Breakthrough Therapy Designations: Depression, Headaches, Hepatitis

The latest developments in one of the US FDA's favorite pathways.

US FDA Performance Tracker Review Pathway

US FDA Drug Development Tool Qualification Takes Center Stage At December Meeting

Public session to gather input on taxonomy and scientific criteria for qualifying animal models, biomarkers and clinical outcome assessments is early step toward satisfying 21st Century Cures Act requirements and PDUFA VI commitments.

Research & Development Animal Testing

Big Share Of EU Decentralized Procedures Still Seeking Post-Brexit Home

Progress is being made with redistributing UK rapporteurships for non-centrally approved medicines, but companies need to keep up the momentum if all procedures are to be reallocated to other EU countries by the Brexit date of March 29, 2019.

Brexit Life Cycle Management

The Strategic Advantages of Early Access Programs

Providing access to unlicensed medicines can offer companies big strategic advantages.

Market Access Regulation

EU Accelerated Assessment Tracker: Second Half Trumps First By Far

The first half of the year was pretty bleak for companies seeking fast-track review of their products in the EU. There has been much better news in the second half. The Pink Sheet tracks the winners and losers.

Europe European Performance Tracker

Bring Them On: 40 Orphan, Cancer Drugs Set For Priority Review In China

New treatments for spinal muscular atrophy, glioblastoma, Gaucher's disease and others could be soon be hitting the China market following the awarding of priority reviews to a large list of novel therapies.

China Rare Diseases

Lack Of Priority? No ANDAs Approved Using Expedited Pathway In FY 2018

US FDA also refused to receive many priority generic drug applications, suggesting the expedited pathway may not be working as intended quite yet.
Generic Drugs Review Pathway

Overseas Regulator Helps Ipsen Score A First In Australia

Ipsen’s tyrosine kinase inhibitor, Cabometyx, is the first product to be registered under a new Australian procedure that aims to get prescription drugs to market faster by using medicine assessments already conducted by comparable overseas regulators.

Australia Approvals
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