Clinical Outcome Assessments (COA) Qualification Program Submissions

CGMP/Finished Pharmaceuticals/Adulterated

The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/17/2020
Short Title (70 char) Jose F. Cardona, M.D. Hialeah, FL. EIR issued 11/17/2020
FEI Number 3008031588
Firm Name Jose F. Cardona, M.D.
Record Type EIR
State FL
Establishment Type Clinical Investigations

FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performanc

IMPRIS corrects IMRIS Neuro III-SV models due to the potential of ice blockage in the helium venting pipe

This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to present).