The FDA/Industry agreement for PDUFA VI envisions a relatively modest increase in the amount of user fees paid by brand name companies; the length of the “commitment letter” outlining the agreement, however, expanded dramatically.
When the Prescription Drug User Fee program began in 1992, the fee set for each new drug application was $100,000. Twenty-five years later, the fee is almost $2.4 million.
PDUFA now generates over $800 million in revenues for FDA, more than 60% of the agency’s total spending on human...
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Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.
