We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Clarifies PSP Submission Timeline, Contents in Guidance
FDA Clarifies PSP Submission Timeline, Contents in Guidance
July 19, 2013
Drugmakers should submit pediatric study plans (PSP) “no later than 60 calendar days” following conclusion of their end-of-phase 2 development meeting with the FDA, a newly released draft guidance clarifies.