Article, FDA and World Health - Health Care Compliance Brief

Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

NOVEMBER 17, 2022

A full posting of abstracts/summaries of these articles may be found on our? Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Reforming the World Health Organization’s Essential Medicines List: Essential but Unaffordable. JAMA Intern Med. 2022 Oct 3:e224226.

FDA

FDA World Health Medicaid Medicaid

AI’s Ability to Manipulate Decision Making Requires a Moratorium on Its Use in Obtaining Consent for Biomedical Research

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

Informed Consent FDA Public Health World Health

Better Health Care Tests, Faster

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

COVID-19 Nurses FDA Licensing

Psychedelic Inequities and Unexplored Risk: Colonization, Commercialization, and Regulation

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

Governance FDA World Health Health Outcomes

Digital Transformation Relies on Data Center Storage

Healthcare IT Today

JULY 12, 2023

The following is a guest article by Ken Parent, CEO at Element Critical As the healthcare landscape continues to evolve, there has been significant disruption to budgets, manpower, and resources throughout healthcare facilities. The primary drivers of these developments are outcomes, cost, and experiences.

Telemedicine

Telemedicine FDA World Health Health Outcomes

How the Medical Industry Can Help Combat the Current Coronavirus Crisis

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

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

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

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

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

SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

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

FDA Compliance COVID-19 World Health

SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

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. The addition of Annex 2, which describes the CPCA for N -nitrosamines.

FDA

FDA Compliance Licensing World Health

SQA Regulatory Surveillance Summary | Monthly Update 2022 – May

SQA

JULY 8, 2022

Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. World Health Organization (WHO). of devices worldwide have experienced this problem. WHO Pharmaceuticals Newsletter, No.

Pharmaceutical Industry

Pharmaceutical Industry FDA Hospitals World Health

SQA Regulatory Surveillance Summary | Monthly Update 2022 – July/August

SQA

OCTOBER 18, 2022

Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus. United States Food and Drug Administration (FDA) – Regulations and Guidances. PDA Technical Report No.

US Department of Health and Human Services

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

SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

FEBRUARY 26, 2024

” If the product is prohibited in Brazil, a notice of infraction is drawn up for smuggling of goods (Article 334 A, item II, of the Criminal Code), which is then sent to the Public Prosecutor’s Office for criminal investigation. After this period, the product is characterized as an “abandoned commodity.”

FDA

FDA Compliance COVID-19 Public Health

FDA’s Brief To The Fifth Circuit in the AHM Case Is Worth A Read

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

FDA COVID-19 Public Health World Health

Health Care Compliance Brief

Monthly Round-Up of What to Read on Pharma Law and Policy

AI’s Ability to Manipulate Decision Making Requires a Moratorium on Its Use in Obtaining Consent for Biomedical Research

Trending Sources

Better Health Care Tests, Faster

Psychedelic Inequities and Unexplored Risk: Colonization, Commercialization, and Regulation

Digital Transformation Relies on Data Center Storage

How the Medical Industry Can Help Combat the Current Coronavirus Crisis

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA Regulatory Surveillance Summary | Monthly Update 2022 – May

SQA Regulatory Surveillance Summary | Monthly Update 2022 – July/August

SQA Regulatory Surveillance Summary | Monthly Update 2024

FDA’s Brief To The Fifth Circuit in the AHM Case Is Worth A Read

Stay Connected