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California Enters Insulin Manufacturing: Can We Expect to See a California Effect?

Bill of Health

Once approved by the FDA, CalRx insulin will be made available at $30 to all Californians who need it. This initiative will come with enormous savings to the public: it will bring down the price of insulin by 90%, saving cash-paying patients between $2,000 to $4,000 annually.

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Pharma & Influencer Marketing: Can They Coexist Ethically?

HIT Consultant

Mike Szczesny, Owner & VP of EDCO Awards & Specialties Influencer marketing in the pharmaceutical industry is a complex issue with reasonable arguments on multiple sides. Their role extends beyond simple promotion—influencing public opinions, driving awareness, and ultimately facilitating a positive impact on public health.

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Opill’s FDA Approval: Implications for Pharmaceutical Regulation and Access to Care

Bill of Health

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent. It was a long time coming.

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Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment

Bill of Health

Senator Sanders’ proposal within PAHPA was ultimately struck from the next iteration of the legislation due to concerns from the pharmaceutical industry and others that such a measure would chill innovation. Federal support by BARDA and the CDC have de-risked the development of medical products for the pharmaceutical industry.

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Health Provider News – February 18, 2022

Hall Render

Lawmakers call on Biden to end public health emergency. Meet new FDA chief Dr. Robert Califf: 5 things to know. Outpatient push being felt in architecture industry. 5 recent hospital, health system COO moves. of Public Health website. 8 recent hospital, health system executive resignations.

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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

This technical report focuses on the challenges facing the pharmaceutical industry that use complex packaging systems for sterile drugs and biologics (e.g., Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

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.

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