SQA

SEPTEMBER 2, 2022

On 09 May 2022, NMPA released the draft of the revised Regulations for Implementation of the Drug Administration Law (hereafter referred to as the Regulations ) for public comments. The Regulations were first issued with immediate effect in 2002 and were later revised in 2016.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The Therapeutic Goods (Medical Devices) Regulations 2002 now includes for Essential Principle 7.7: Products that are injected.

FDA 40

FDA Licensing Governance Compliance 40

SQA

DECEMBER 16, 2022

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells.

FDA 40

FDA Compliance COVID-19 Licensing 40

Health Law Advisor

AUGUST 10, 2023

FDA came out with guidance explicitly explaining its reach over hospitals engaged in those reprocessing efforts, [14] and in 2002 Congress validated that extension with an amendment to the underlying statute. [15] FDA serves an important public health purpose of externally validating algorithms that impact patient care.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

AUGUST 2, 2021

ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators. Greater API production domestically will help reduce reliance on global supply chains for medications that are in shortage, particularly during times of increased public health need.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

FEBRUARY 26, 2024

Anyone feeling unwell, for example with symptoms of eye infection, such as reduced vision or red and painful eyes, should contact a healthcare professional and tell them that they have been using a recalled eye gel. These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002.

FDA 52

FDA Compliance COVID-19 Public Health 52