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

Bill of Health

Dose modification rules and availability of growth factor support: A cross-sectional study of head-to-head cancer trials used for US FDA approval from 2009 to 2021. FDA validation of surrogate endpoints in oncology: 2005-2022. Eur J Cancer. 2022 Sep;172:349-356. Epub ahead of print. Walia A, Haslam A, Prasad V. J Cancer Policy.

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Tobacco Issues Awaiting Robert Califf at the FDA

Bill of Health

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes. Reviewing E-cigarettes.

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Cybersecurity is Now a Patient Safety Issue, Suggests Sen. Warner In Congressional Report

HIPAA Journal

The Department of Health and Human Services (HHS) is the Sector Risk Management Agency (SRMA) for the healthcare industry, but within the HHS agencies such as the Office for Civil Rights (OCR), Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA) have their own jurisdictions and cybersecurity policies.

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Digital Documentation: How PDFs Can Help Providers Expedite Care

HIT Consultant

The transition toward more digital recordkeeping in healthcare began in earnest in 2009 with the passage of the American Recovery and Reinvestment Act. If this documentation is primarily paper-based, researchers could have a difficult time ensuring each piece of documentation meets FDA standards.

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Uber Health Hires First Chief Medical Officer, Aledade’s New CEO, Other Digital Health Appointments

HIT Consultant

Big Health , a digital therapeutics company dedicated to helping millions back to good mental health, today announced that it has added former Food and Drug Administration (FDA) Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah to its Board of Directors.

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A Year Later—Revisiting FTC’s Updated Endorsement Guides

Hall Render

Part 255 , had not been updated since 2009, well before the advent of popular social media platforms like TikTok and Instagram and the rise of social media influencers. Could FDA Action Be Next? The FDA has not updated its guidance since 2014. As of July 2024, the FDA has not publicly responded to the letter.

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The Global Challenge of Unhealthy Diets: Front-of-Package Labeling for America

Bill of Health

Since 2009, the U.S. Food and Drug Administration (FDA) is expected to propose new rulemaking on front-of-package labeling in 2024. On the other hand, in 2016, the FDA proposed a new rule requiring food manufacturers to disclose added sugar content on packaging. No standardized system exists but the U.S. While the U.S.