Bill of Health

JULY 14, 2023

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

Informed Consent 130

Informed Consent FDA Public Health World Health 130

Healthcare IT Today

JUNE 13, 2023

The previous articles in this series laid out some of the issues in health care affecting testing , and the value of data. This article looks at some specific problems and solutions. Virax Biolabs uses data from the World Health Organization and others to develop tests quickly.

COVID-19 106

COVID-19 Nurses FDA Licensing 106

Bill of Health

FEBRUARY 27, 2024

Both Robert and Valentina Wasson published sensational magazine articles in Life! Regulatory Process Ideally, a novel therapy will undergo a translational process through which efficacy is determined and the therapy is adapted for delivery in diverse health care settings.

Governance 120

Governance FDA World Health Health Outcomes 120

Exeed Regulatory Compliance

MARCH 5, 2020

It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

SQA

FEBRUARY 15, 2023

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. The application/notification must be submitted via the EUDAMED database (Article 69 IVDR).

US Department of Health and Human Services 40

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

SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. The addition of Annex 2, which describes the CPCA for N -nitrosamines.

FDA 40

FDA Compliance Licensing World Health 40