NOT-FD-14-008: Notice of Change to Patient Population Requirements for RFA-FD-14-024 "Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Cardiovascular Drugs (U01)"

Notice of Change to Patient Population Requirements for RFA-FD-14-024 "Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Cardiovascular Drugs (U01)"

Notice Number: NOT-FD-14-008

Key Dates
Release Date: May 16, 2014

Related Announcements
RFA-FD-14-024

Issued by
Food and Drug Administration (FDA)

Purpose

This Notice is to inform potential applicants of changes to RFA-FD-14-024, "Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Cardiovascular Drugs (U01). Flexibility to patient population requirements will be allowed.

Therefore, the objective of the RFA is modified to allow the conduct of a prospective PK/PD study in patients with cardiovascular diseases to link the PK profiles to the time-course of PD activity of metoprolol and identify the key product attributes and patient factors that may impact the therapeutic equivalence of metoprolol products.

Please note: The application due date for applications in response to RFA-FD-14-024 "Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Cardiovascular Drugs (U01)" is June 1, 2014.

Inquiries

Please direct all inquiries to:

Lanyan (Lucy) Fang
Food and Drug Administration (FDA)
Office of Generic Products
Telephone: 301-796-5005
Email: Lanyan.Fang@fda.hhs.gov