Lachman Consultants Blog Court Rules FDA Erred in Not Granting Pediatric Rare Disease Voucher

In a very interesting decision, the United States District Court for the District of Columbia ruled that the FDA erred in not granting a pediatric rare disease voucher to Sun Pharmaceutical's injectable phenobarbital drug for the treatment of a rare seizure disorder in pediatric patients less than four years of age. The Court cited statutory [...]The post Court Rules FDA Erred in Not Granting Pediatric Rare Disease Voucher appeared first on Lachman Consultant Services, Inc..