SQA

JUNE 10, 2021

Due to the COVID-19 pandemic, there was an increase of 39.2% Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). on regulations published by ANVISA. The deadline for comments is 30 June 2021.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

SQA

AUGUST 8, 2023

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. The measure may allow the expansion of the population’s access to diagnostic procedures in the country.

FDA 40

FDA Compliance COVID-19 World Health 40

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. 19 Medical Rehabilitation Equipment.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

SEPTEMBER 2, 2022

ANVISA published the RDC 702/2022, which repeals some requirements that were instituted to speed market approval of devices needed to treat patients during the height of the COVID-19 pandemic. The Agency recently published the first list of critical medicines for the management of the COVID-19 pandemic.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

AUGUST 2, 2021

COVID-19 Response: Freely Available ISO Standards, 18 June 2021. A number of ISO standards have been made available to support global efforts to address the COVID-19 crisis. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. b) and 320.31(d)(3)).

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

FDA 52

FDA COVID-19 Compliance Governance 52

SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides.

FDA 52

FDA Compliance COVID-19 Public Health 52