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24 product(s) and free and sample content

From: Pink Sheet

Pink Sheet: global policy and regulatory coverage

Unparalleled access to global pharma regulatory and compliance intelligence and expertise.

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Pink Sheet

'Progressive Approval' Coming? US FDA Considers Accelerated Approval Without Surrogates

By Derrick Gingery 07 Dec 2017

Commissioner Gottlieb tells Congress that concept could be used for some clinical endpoints when a large benefit is seen in a small trial.

Topic Drug approval

Pink Sheet

Supplemental Oncology Approvals: 'Reverse Accelerated Approval,' Not Lowering The Bar

By Sue Sutter 07 Dec 2017

Sometimes data supporting drug's initial approval can serve as confirmatory evidence for full approval of a subsequent indication.

Topic Drug approval

From: Biomedtracker

Biomedtracker: follow the drug development process

Track and assess key events that will impact a drug’s probability of technical success and approval.

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  • Conference coverage

Biomedtracker

BMT Q4 Outlook Report

27 Oct 2017

In this report, we cover catalysts from 21 drugs expected to occur in Q4 2017. For each drug, the likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided.

Topic Alzheimers Cancer Drug approval

Biomedtracker

Report Extract: Q3 2017 Outlook Report

17 Jul 2017

In this report, we cover catalysts from 21 drugs expected to occur in Q3 2017. For each drug, the likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided.

Topic Alzheimers Cancer Drug approval

From: Portfolio Management Solutions

Portfolio Management Solutions

We help you understand the expected value and associated risks across your drug development portfolio.

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