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

Bill of Health

By Aparajita Lath For over 100 years, policy makers and pharmaceutical manufacturers in the U.S. have debated whether the government should produce drugs and biologics. Until now, private industry has largely won– but that may be changing, due to a recent California initiative. Now, the tide is turning.

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Streamlining Compliance in the Pharmaceutical Industry with the eQMS

Dot Compliance

In the pharmaceutical industry, the importance of regulatory compliance extends beyond fulfilling legal obligations. Compliance can be streamlined with the help of an electronic quality management system (eQMS) that incorporates regulatory standards into every operational aspect of a pharmaceutical organization.

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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

Such a provision could prevent the public from paying twice for publicly-funded medical products—first through their taxes subsidizing government funded research and development, and second to procure the product in an inflated U.S. pharmaceutical market. Moreover, the NASDAQ Biotechnology Index increased by 374% from 1995 to 2000.

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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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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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SQA Regulatory Surveillance Summary | Monthly Update 2022 – May

SQA

It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products. 88, Microbial Data Deviation Investigations in the Pharmaceutical Industry, January 2022. However, it can provide general guidance during the assessment of regulatory requirements.

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Prescription Drugs: From Costs and Bad Reputation to Civica Rx and Amazon to the Rescue

Health Populi

consumers have long-ranked the pharmaceutical industry relatively low, but above car salespeople and the Federal government. In Gallup’s latest poll on Americans’ industry rankings, both healthcare and pharma fell to the lowest net favorability score with the Federal government at rock bottom.