GDUFA’s Perfect Storm: Approvals Drop, Submissions Jump
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.
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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.
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.
Agency announces new prescription drug, generic drug and biosimilar rates – with one fee increasing more than 47%.