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

Bill of Health

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. Limitations on the Capability of the FDA to Advise. JAMA Intern Med. 2022 Oct 3:e224226. Epub ahead of print.

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Femtech – Changing Dynamics of Women’s Healthcare

HIT Consultant

Femtech a term coined by Danish entrepreneur Ida Tin in 2016 has become a revolutionary moment for women across the globe. Femtech as the term suggests focuses on using technology to solve health issues in females. World Health Organization states that 48 million couples face infertility problems.

FDA 98
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SQA Regulatory Surveillance Summary for January and February 2024

SQA

Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules. Last year, the World Health Organization (WHO) issued an alert about cough syrups being contaminated with diethylene glycol and ethylene glycol, which are toxic to humans and can prove fatal.

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The Global Challenge of Unhealthy Diets: Front-of-Package Labeling for America

Bill of Health

Food and Drug Administration (FDA) is expected to propose new rulemaking on front-of-package labeling in 2024. The World Health Organization (WHO) has recommended FOP labeling as a cost-effective intervention to improve population-level dietary habits. Since 2009, the U.S. No standardized system exists but the U.S.

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

SQA

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.

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

Drug & Device Law

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.

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