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Review Pathways

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New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

European Performance Tracker Drug Review

Celgene, Agios Drug Enasidenib Among New Filings At EMA

Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.

Drug Review Review Pathway

GSK's Tafenoquine Faces Questions Over Review Pathways At US FDA Panel

Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.

Advisory Committees Drug Review

Breakthrough, Priority Review Designations Could Set High-Water Marks In 2018

Announcements of designations for both US FDA's expedited pathway are on torrid paces through first half of 2018. 
Drug Review Review Pathway

US FDA Seeking More ‘Open Access’ To Real World Data From Payers

Agency is paying “enormous sums” to access postmarket information from payers, Commissioner Gottlieb says, suggesting public-private partnerships to enhance access.

Drug Safety Private Payers

US FDA's Rare Diseases Program Not Expected To Change With Drug Office Reorg

Reviewer expertise may be better leveraged in more focused roles, but basic tenets of rare disease program should not fundamentally change as part of proposed Office of New Drugs reorganization.

Review Pathway Rare Diseases

RMAT Designation Requests May Rise Or Fall On Manufacturing Changes, Clinical Data Breadth

Product characterization questions and partial or inconsistent clinical data are among the more common reasons why the US FDA denies, or seeks additional information about, a request for regenerative medicine advanced therapy designation, FDA’s Bryan says; sponsors should consider why they are seeking designation when deciding whether to apply for RMAT, breakthrough therapy or both.

Regenerative Medicine Review Pathway

Clinuvel’s US Filing For EPP Drug Scenesse Includes Real World Evidence From Europe

Clinuvel says real world evidence from the experience of European patients is a key part of the submission it has just made to the US FDA for its ground-breaking phototoxicity therapy, Scenesse (afamelanotide). The company also plans to apply its one-price policy for the product in the US.

United States Drug Review

EU Speedy Review Request For J&J’s Esketamine

J&J is hoping its experimental new drug for treatment-resistant depression will join the select group of products benefitting from speedy review in the EU.

Review Pathway Europe
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