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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

By Nikhil Chaudhry and Reshma Ramachandran Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19. pharmaceutical market.

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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

COVID-19 Response: Freely Available ISO Standards, 18 June 2021. A number of ISO standards have been made available to support global efforts to address the COVID-19 crisis. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. b) and 320.31(d)(3)).

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies. It provides a practical guide for the pharmaceutical industry on how to implement PACs within the framework of an effective Pharmaceutical Quality System (PQS) and in alignment with ICH quality guidelines.

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Health Provider News

Hall Render

health-tech startup MemoryWell pivots, eyes new funding to roll out software for insurers Department of Veterans Affairs health system kicks off multiyear Greater Washington expansion Georgetown to open Southeast D.C.