Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Review Pathways

Set Alert for Review Pathways

Latest From Review Pathway

Stress Test: Coronavirus Challenges China Emergency Approval Mechanism

A regulatory pathway set up in China post-SARS is under stress test in the latest coronavirus outbreak, while emergency measures adopted by the country's regulator mean it’s much less burdensome to obtain approvals than before.

Review Pathway Regulation

China Unlikely To Be Included In US FDA's Project Orbis In The Near Term

Oncology Center of Excellence Director Pazdur says there must be confidence that confidentiality agreements are universally accepted in response to request that China be included in the multi-regulator application assessment program.

Drug Review Cancer

Gene Therapies: US FDA Sticks With Bleeding Rate For Hemophilia Approval Endpoint

Although clotting factor activity levels may someday be validated as a surrogate endpoint, the currently recommended primary efficacy measure for traditional approval remains annualized bleeding rate, agency says in final guidance.

Gene Therapy Drug Approval Standards

PDUFA VII: Will Gene Therapy's Rise Influence Talks?

The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.

Gene Therapy User Fees

GDUFA III: How Much Of A Fee Increase Can Industry Stomach?

Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.

Generic Drugs Review Pathway

Predicting The User Fee Reauthorization Schedule

PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.

User Fees Review Pathway

BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?

Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.
User Fees Biosimilars

Keeping Track: Aimmune’s Peanut Allergen Approved; Novartis’ Inclisiran, Pfizer/Lilly’s Tanezumab, Bayer’s Nifurtimox Submitted

Highlights of the latest drug development news from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives

US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.

Review Pathway Vaccines
See All
UsernamePublicRestriction

Register