Bill of Health

APRIL 7, 2022

Article 6 of the TRIPS states that “the exhaustion of intellectual property rights” is left to “each Member free to establish its own regime for such exhaustion without challenge,” a topic that was front and center of the 1998 to 2001 litigation between drug companies and South Africa. Geographic restrictions on both imports and exports.

COVID-19 363

COVID-19 COVID-19 Vaccine Licensing Public Health 363

MedTrainer

DECEMBER 7, 2023

The West Virginia Hospital Association (WVHA) is a collective organization that represents and supports hospitals and health systems across West Virginia, advocating for quality healthcare services and the improvement of health standards within the state.

Compliance 52

Compliance Licensing Medicaid Medicaid 52

SQA

SEPTEMBER 2, 2022

The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.

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. It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities.

FDA 40

FDA Compliance COVID-19 Licensing 40

Drug & Device Law

JANUARY 4, 2024

The PREP Act goes into effect upon a federal declaration of public health emergency. The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005: To encourage the expeditious development and deployment of medical countermeasures during a public health emergency. . . [by] 247d-6d(b)(8).

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59