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

Bill of Health

The selections feature topics ranging from how Wikipedia pages communicate drug efficacy information, to addressing pharmaceutical industry payments to physicians, to the frequency with which the Food and Drug Administration removes hazardous dietary supplements from the market. 2022 Jul 19:S0895-4356(22)00182-2.

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3 Lessons Learned from Pandemic-Era Clinical Development Regulatory Practices

HIT Consultant

The pandemic has given rise to new norms in drug development that will influence the future of the industry as we know it. The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools. Here’s a look at what we’ve learned from COVID-19 era regulatory practices in clinical development.

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How the Life Sciences Industry Can Boost Diversity and Inclusion Efforts

HIT Consultant

The FDA is attempting to address this, having issued guidelines related to diversity in clinical trials in November 2020 – perhaps prompted by widespread media coverage of the fact that the black members of the society and other people of color were underrepresented in clinical trials for COVID-19 vaccines.

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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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Overcoming Key Hurdles in Decentralized Trials with Better Education

HIT Consultant

As with countless global industries, clinical trials were forced to move key functions online as COVID-19 swept the world in early 2020. Further underscoring this trend, 93% of sites also reported that they would allow sponsors or CROs to conduct remote monitoring, compared to 74% pre-COVID. About Robert Geckeler.

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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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Health Provider News – February 18, 2022

Hall Render

CMS may now enforce its COVID-19 vaccination policy for healthcare workers in all 50 states. HHS seeks $30B to combat COVID-19. Meet new FDA chief Dr. Robert Califf: 5 things to know. As Alabama COVID numbers fall, ICUs across the state remained slammed. Million in Covid Relief. CALIFORNIA.