Health Populi

AUGUST 12, 2020

While I’m on holiday this week, restoring and re-setting, I’ve been sharing pages from my ABCovid-19 Journal with readers of Health Populi. This “P” was self-evidence in our collective early COVID-19 lexicon. I created this journal during the early phase of the pandemic in the U.S., R is for risk.

COVID-19 93

COVID-19 Public Health FDA World Health 93

Exeed Regulatory Compliance

MARCH 5, 2020

A novel coronavirus, now called SARS-CoV-19, was first detected in the Hubei province of China in early December 2019. 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

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. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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

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

SQA

DECEMBER 16, 2022

19 Medical Rehabilitation Equipment. Medicine shortages and reduced availability of medicine represent an increasing issue across the European Union (EU) and the globe, which has been amplified by the COVID-19 pandemic. United States Food and Drug Administration (FDA) – Regulations and guidance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

Bill of Health

AUGUST 8, 2022

On August 4, 2022, Health and Human Services (HHS) Secretary Xavier Becerra declared monkeypox a national public health emergency (PHE). Unlike COVID-19, monkeypox infection is not usually fatal, but its symptoms can be painful and disabling. As seen repeatedly during the COVID-19 pandemic, U.S.

COVID-19 144

COVID-19 Public Health FDA Medicaid 144

Health Populi

AUGUST 31, 2023

The phenomenon of medical mis-information accelerated during the COVID-19 pandemic, normalizing weird anti-science and culminating in the rejection among many U.S. health citizens of the vaccine fast-tracked to address the worst effects of the coronavirus. KFF fielded the study in May and June 2023, finding that most U.S.

COVID-19 111

COVID-19 COVID-19 Vaccine Public Health FDA 111

SQA

OCTOBER 18, 2022

Health Canada. Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022. Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. Health Advance Inc. PDA Technical Report No.

US Department of Health and Human Services 40

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

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

MAY 11, 2023

A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. The appellate brief from FDA bears that out well.

FDA 59

FDA COVID-19 Public Health World Health 59

Drug & Device Law

APRIL 7, 2022

Over the past seven months, we reported ( here , here , here , here , here , and here ) on cases in which relatives of individuals sick with COVID-19 sued to force hospitals to administer ivermectin to their loved ones. Christiana Care Health Servs., Jones , 637 S.W.3d 3d 202, 207 (Tex. 3d 423, 435 (Del.

COVID-19 105

COVID-19 FDA Doctors World Health 105