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

Bill of Health

FEBRUARY 27, 2024

There is a common and problematic misconception that colonization was an isolated historical event and that the present is somehow divorced from its precedent. To explore how colonization drives health inequities, we have to acknowledge the causal relationship between what is past and what is present and think critically about colonization.

Governance 120

Governance FDA World Health Health Outcomes 120

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. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

US Department of Health and Human Services 40

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

SQA

JULY 8, 2022

The ICH E8(R1) Introductory Training Presentation Now Available on the ICH Website, 27 April 2022. A Step 4 Introductory Training Presentation has been developed by the E8(R1) Expert Working Group and is now available on the ICH E8(R1) webpage with the Step 4 ICH E8(R1) Guideline. World Health Organization (WHO).

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

DECEMBER 16, 2022

The EC presented a first draft for public comment to the revision of Annex 1 in 2017. The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA GMP/GDP Inspectors Working Group (GMDP IWG) in close co-operation with the European Commission (EC) and the World Health Organization (WHO).

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

AUGUST 8, 2023

The main innovations presented in the new standard are: Increased scope of the standard, with the inclusion of anatomopathological and toxicology laboratories, among others. PCPC has long supported providing the FDA with the resources it needs to advance modern federal regulatory oversight of cosmetics and personal care products.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. about how they use sunscreen products.

FDA 40

FDA Compliance Licensing World Health 40