Bill of Health

OCTOBER 31, 2022

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes , creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development. However, the act of submitting an application to the FDA based on such research (e.g.,

COVID-19 173

COVID-19 COVID-19 Vaccine Licensing FDA 173

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 Regulations were first issued with immediate effect in 2002 and were later revised in 2016.

FDA 91

FDA COVID-19 Nursing Homes Public Health 91

SQA

DECEMBER 16, 2022

19 Medical Rehabilitation Equipment. This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells. United States Food and Drug Administration (FDA) – Regulations and guidance. CMDE Announcement No. 04 Orthopedic Surgical Instruments. 09 Physiotherapy Equipment.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 52

FDA Compliance COVID-19 Public Health 52

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. ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators. b) and 320.31(d)(3)).

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 40

FDA Compliance COVID-19 Public Health 40

Drug & Device Law

JANUARY 4, 2024

So we do have comments on the bizarre complaint that the Texas attorney general recently filed over COVID-19. The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. FDA (8/23/21) press release (emphasis original).

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59