Pediatric Studies Could Be Required For Most Lymphomas, Leukemia
FDA may invoke the pediatric rule to require studies for most lymphomas and leukemias, members of the Oncologic Drugs Advisory Committee's Pediatric Subcommittee recommended April 24.
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FDA should consider supporting "wild card" pediatric exclusivity which would allow companies to apply patent extensions to a product of their choice in return for performing needed pediatric research, Oncologic Drugs Advisory Committee member Henry Friedman, MD, Duke University Medical Center, suggested.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials