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Sen. Edward Kennedy (D-Mass.) introduced the Prescription Drug User Fee Act (PDUFA) reauthorization last week, proposing a new structure that would increase the agency’s user fees by more than $100 million.
Pediatric drug study costs increased nearly eightfold between 2000 and 2006, while the studies have become larger and more frequent, a study from the Tufts Center for the Study of Drug Development said.
Pediatric drug study costs increased nearly eightfold between 2000 and 2006, while the studies have become larger and more frequent, a study from the Tufts Center for the Study of Drug Development said.
Pediatric drug study costs increased nearly eightfold between 2000 and 2006, while the studies have become larger and more frequent, a study from the Tufts Center for the Study of Drug Development said.
The FDA is reviewing the safety and efficacy of cough and cold medications for children to decide whether the methods used to determine dosages were sufficient, the agency announced.
Implementing the new pediatric medicines legislation will be a major priority in the coming year and will have an impact on existing core activities, such as scientific advice, quality and risk management and postmarketing surveillance, the European Medicines Agency (EMEA) says in its 2007 Work Program.
The Centers for Disease Control and Prevention (CDC) has added Merck’s cervical cancer vaccine to its vaccine program for children ages 9–18. Gardasil will now be part of the CDC’s Vaccines for Children (VFC) contract, Merck announced.
The European Commission and the European Medicines Agency (EMEA) have issued a joint document setting priorities for implementing new safeguards for drugs intended for use in children, anticipated to take effect in January 2007.