FDA’s Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.
Similar Posts
BlendHouse LLC. Reading, PA. EIR issued 02/17/2023
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/17/2023
Short Title (70 char) BlendHouse LLC. Reading, PA. EIR issued 02/17/2023
FEI Number 3015728839
Firm Name BlendHouse LLC
Record Type EIR
State PA
Establishment Type ManufacturerFrom Our Perspective
Insights from CDER leadership and experts on public health actionsContinuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.Emerging Technology Program (ETP)
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.www.portmeds.com – 711585 – 07/16/2025
Unapproved New Drugs/MisbrandedApollo Care LLC. Columbia, MO. 483 issued 03/27/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 03/27/2025
Short Title (70 char) Apollo Care LLC. Columbia, MO. 483 issued 03/27/2025
FEI Number 3013927023
Firm Name Apollo Care LLC
Record Type 483
State MO
Establishment Type Outsourcing Facility