US FDA explains how drug makers can meet new pediatric study plan requirement
This article was originally published in SRA
The US Food and Drug Administration has issued draft guidance on how drug sponsors can meet a new rule that requires manufacturers subject to the Pediatric Research Equity Act to submit a pediatric study plan (PSP) early on in the drug development process1.
You may also be interested in...
Drug companies have their last chance to negotiate which documents and information Italy’s regulator, AIFA, will be entitled to request of them when they submit pricing and reimbursement applications.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
New medicines under evaluation at the European Medicines Agency.