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Review Pathways

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Minimal Residual Disease 'Coming Soon' As An Approval Endpoint, Celgene Says

Celgene's ASH briefing notes 'unprecedented' MRD-negative data in Phase I study in multiple myeloma development program for CAR-T therapy bb2121; firm sees potential opportunity for the marker to pave way for approval in earlier-line settings of the disease.

Drug Approval Standards Review Pathway

Opioid Packaging: Is Non-Inferiority Enough For A New Claim?

Industry exec suggests new packages need be merely no worse than the classic amber vial to gain a claim, but US FDA says packaging intended to fight abuse should be better.

Review Pathway Innovation

Complete Response Letters: Firms See Value In Public Release, Don't Expect It Will Happen

One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.

Complete Response Letters Drug Review

Sanofi's Admelog, a Humalog Follow-On, Approved In US As 'Black Hole' For Insulins Looms

Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.

Approvals Biologics

Breakthrough, Fast-Track Pathways Match Their Hype Of Reduced Development Times - JAMA

Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.

Review Pathway Drug Approval Standards

GDUFA II Reviews Start Strong With High First-Cycle Approval Rate

Performance numbers are likely to fluctuate over the course of the program, but the rate of first-cycle approvals during the first month of the new user fee program is more than double the rate during the last year of the old iteration. 

Generic Drugs Review Pathway

US FDA May Create Immunology, Neuroscience Centers Of Excellence

Commissioner Gottlieb says new centers would follow template of Oncology Center of Excellence.

Review Pathway Neurology

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

Commissioner Gottlieb tells Congress that concept could be used for some clinical endpoints when a large benefit is seen in a small trial, which could benefit rare disease drug development.

Review Pathway Drug Approval Standards

Unhappy With GDUFA II? Note It For GDUFA III, FDA Says

US agency says it is implementing generic drug user fee program as outlined in commitment letter and any changes should be discussed at negotiations for the 2022 renewal.

Generic Drugs Review Pathway
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