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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.

FDA 184
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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 | 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.

FDA 59