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No More 'Hidden' Facilities, US FDA Tells Generic Sponsors

Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.

Generic Drugs Review Pathway

FDA Contradicts AAM's Generic Market Consolidation Argument

As the generic industry trade group warns shortages could emerge as number of manufacturers contracts, US FDA says many new firms gaining approvals and identifying facilities.

FDA Generic Drugs

US FDA's Oncology Division Wants To Know About Your Pipeline, Not Just Your NDAs

Oncology Center of Excellence Director Richard Pazdur says agency invites sponsors to present about molecules under development to learn more about future plans.

Review Pathway Cancer

AstraZeneca On Bridging The Gap Between Accelerated Approval And HTA Requirements

Health technology assessment agencies are struggling to evaluate drugs on the basis of evidence generated for early approvals, says AstraZeneca.

BioPharmaceutical Approvals

Accelerated Development On The Cards In EU and US For Bluebird, Celgene’s CAR-T Therapy

Bluebird Bio and Celgene have secured a place on both the EMA’s PRIME scheme and the US FDA’s breakthrough therapy designation program for their multiple myeloma CAR-T therapy, bb2121. Meanwhile, Bluebird talks about how “incredibly helpful” PRIME has been with the development of LentiGlobin for beta-thalassemia.

Review Pathway Europe

US FDA Drug Office Reform: 'Everything' Is On The Table

Deputy Office of New Drugs director says IND evaluation and post-market surveillance could be part of restructuring effort along with changes to application review.

Drug Review Review Pathway

New ANDA Review Pathways: Should You Be A Priority Or Expedited?

Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.

Generic Drugs Review Pathway

More ANDAs To Be Eligible For Priority Review, Gottlieb Says

US FDA Commissioner says agency has necessary resources to expand priority review pathway even as multiple review cycles for generic applications remain common.

Generic Drugs Review Pathway

Priority Review Designations In US: Third Quarter Spike Continues In 2017

Third quarter saw record total of 26 announcements for priority review designations; drop-off now likely.

Review Pathway FDA
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