SQA

APRIL 30, 2021

726/2004, 09 March 2021. 726/2004 , which essentially means duplicate MAAs for products authorized via the centralized procedure. These missions will allow the Commission to identify, and, if necessary, correct any non-compliance or weaknesses. World Health Organization (WHO).

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

OCTOBER 18, 2023

The following is a summary of a Canadian case report that was evaluated by Health Canada, describing an error associated with confusion about the labelled strength of a mineral supplement: In this case, the prescription was dispensed by the pharmacy using a product labelled as Calcium Carbonate 500 mg. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2023

While preparing the patient’s compliance pack, the pharmacy misinterpreted the product to contain 500 mg of Calcium Carbonate when each tablet actually contained 500 mg of elemental Calcium. CGMP compliance is the floor and FDA is looking for companies to exceed those standards. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40