(A) This part applies to all clinical investigations regulated by the Food and DrugAdministration under sections 505(i) and 520(g) of the Federal Food, Drug, and CosmeticAct, as well as clinical investigations that support applications for research or marketingpermits for produc…
Safe and effective medicines for children: studies conducted under the Best Pharmaceuticals …
by Institute of Medicine (États-Unis)., Board on Health Sciences Policy, Field, Marilyn J., (Marilyn Jane), Boat, Thomas F., Institute of Medicine (U.S.)., Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA)
"The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted…
Safe and effective medicines for children: studies conducted under the Best Pharmaceuticals …
by Institute of Medicine (U.S.)., Board on Health Sciences Policy, Field, Marilyn J., (Marilyn Jane), Boat, Thomas F., Institute of Medicine (U.S.)., Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA)
"The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted…