Bill of Health

NOVEMBER 17, 2022

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. Limitations on the Capability of the FDA to Advise.

FDA 184

FDA World Health Medicaid Medicaid 184

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 26, 2024

The Agency has worked to combat the irregular practice of using cosmetics as injectables since last year, when the first serious adverse events involving this type of product occurred. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

FDA 52

FDA Compliance COVID-19 Public Health 52

SQA

AUGUST 8, 2023

Experience with large-scale events such as Hurricane Maria and the COVID-19 pandemic, and more recent geopolitical events, have cast a wider lens on global supply chain and distribution vulnerabilities. The model provides expanded guidance that reflects new insight and best practices that have emerged in the past several years.

FDA 40

FDA Compliance COVID-19 World Health 40

Bill of Health

MARCH 27, 2023

Neither event has happened here. Instead, like HIV, which continues to be an ongoing public health emergency , the virus continues to infect and mutate. All of this might make sense in a world where COVID has gradually become less prevalent and less of threat. But, if that world exists, it is somewhere in another dimension.

COVID-19 332

COVID-19 Public Health Governance COVID-19 Vaccine 332

Exeed Regulatory Compliance

MARCH 5, 2020

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

US Department of Health and Human Services 52

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

SQA

OCTOBER 18, 2023

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products. To be injectable, the product must be registered with the Agency as a medicine or health product.

FDA 40

FDA Compliance Licensing World Health 40