Bill of Health

APRIL 7, 2022

On March 15, 2022, STAT published text of a proposed compromise at the World Trade Organization (WTO) to temporarily relax global standards for intellectual property for COVID-19. In short, the compromise only waives a single 20-word paragraph in one article: the one dealing with exports under a non-voluntary authorization.

COVID-19 363

COVID-19 COVID-19 Vaccine Licensing Public Health 363

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

DECEMBER 16, 2022

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. 19 Medical Rehabilitation Equipment. It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 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. 247d(a), 247d-6d(a)(1). 247d-6d(a)(2)(A)(i).

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59