Unapproved New Drugs/Misbranded/Botox
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Generic Drug User Fee Amendments
FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner.Biomarker Qualification Program
The Drug Development Tools (DDT) Research Grant Cycle for Fiscal Years (FY) 2024 is now open.Hikma Injectables USA Inc. Dayton, NJ. 483 issued 08/08/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Hikma Injectables USA Inc. Dayton, NJ. 483 issued 08/08/2025
FEI Number 3022897129
Firm Name Hikma Injectables USA Inc.
Record Type 483
State NJ
Establishment Type Outsourcing FaUpdate: FDA Encourages the Public to Follow Established Choking Rescue Protocols – FDA Safety Communication
These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting systemAvoiding Products Contaminated with Hidden Ingredients
Many products claiming to help with health issues hide dangerous drug ingredients. Get informed about how to avoid contaminated products and their hidden ingredients.