PhRMA Wants Prompt PSPs to Bring Earlier Waivers/Dismissals

September 26, 2013
Drugmakers that submit Pediatric Study Plans (PSPs) early in the drug development process should be rewarded by the FDA with early decisions on the proposals, allowing them to begin product development more quickly than their counterparts that wait until later, PhRMA believes. As it stands now, early submission and acceptance of a PSP doesn’t translate into an earlier final waiver or deferral decision by the agency — there is still a timing “disconnect,” the group says in comments on the agency’s draft guidance.
Washington Drug Letter