Bill of Health

DECEMBER 20, 2022

While not exhaustive, this blog post explores some of the major legal issues likely to arise if a device like the Sarco were to be introduced into the United States. FDA Approval. Food and Drug Administration (FDA), which “ regulates the sale of medical device products (including diagnostic tests) in the U.S.

FDA 245

FDA Doctors Informed Consent Bioethics 245

SQA

FEBRUARY 15, 2023

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. Efforts should be made to promote and guide the use of electronic certificates.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

SQA

MAY 17, 2022

SQA Regulatory Surveillance Summary 2022 – Spring. Brazil’s ANVISA Issues Registration Rules for Software, 01 April 2022. ANVISA has published new regulations focused on software as a medical device (SaMD), set to take effect on 01 July 2022. Agência Nacional de Vigilância Sanitária (ANVISA).

FDA 75

FDA Compliance Informed Consent Hospitals 75

Healthcare Law Blog

AUGUST 9, 2023

The now-active provisions include a prohibition on abortions after 12 weeks of pregnancy (with limited exceptions), 72-hour informed consent requirements, pre-abortion gestational age verification, and reporting requirements for abortions after 12 weeks. [21] United States FDA , 2023 U.S. 5, 2022 Leg., 10, 2022).

Licensing 52

Licensing Informed Consent Nurses FDA 52

Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Instead, Zofran turned mainly on animal studies – three Japanese studies that were not “newly acquired information” that could avoid preemption. They excluded bogus expert testimony under Fed.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105