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


GDUFA’s Perfect Storm: Approvals Drop, Submissions Jump

Executive Summary

FDA increases “complete response” and refuse-to-receive actions in the first half of FY 2014 compared to the previous year, efforts the agency says will move pending applications closer to approval.

You may also be interested in...

Chinese Companies Mull New Markets As Home Growth Slows

At a recent industry conference in Shanghai, experts discussed the recent slowdown in the Chinese pharma sector, while noting that there are still many positive factors for growth in the country. As a pioneer in the U.S. market, Huahai Pharm also shared experiences that might help other Chinese firms expand overseas.

Sagent Turns Generic Injectable Shortages Into Business Opportunity

The specialty generic manufacturer has a facility dedicated to producing shortage drugs, a seemingly endless commercial opportunity given the development, regulatory and reimbursement challenges in the sterile injectable space.

FDA User Fees In FY 2014: Burden Per Application Grows As Submission Projections Fall

Agency announces new prescription drug, generic drug and biosimilar rates – with one fee increasing more than 47%.

Related Content





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts