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

Bill of Health

Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership. Changes in the Number of Continuation Patents on Drugs Approved by the FDA. The Regulatory Repercussions of Approving Muscular Dystrophy Medications on the Basis of Limited Evidence. Ann Intern Med. 2023 Aug 22. Epub ahead of print.

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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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Retail Clinics’ Growing Role in Health Care and Prescription Drug Sales

Jane Sarashon

This coalition of patient advocacy organizations includes AIDS United, the Allergy & Asthma Network, the American Kidney Fund, Autism Speaks, Black Women’s Health Imperative, the Crohn’s & Colitis Foundation, the Global Liver Institute, National Consumers’ League, and many other patient-driven coalitions. .”

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Heart Health at #CES2019 – Food and Tech as Medicine

Health Populi

This week’s heart-and-food tech announcements at #CES2019 coincide with an FDA recall on a popular drug prescribed to treat hypertension (high blood pressure). In this category, I point to PEAR Therapeutics , which has a portfolio of FDA-cleared digital therapeutics (DTx) offerings. Limiting alcohol consumption.

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Addressing the Diversity Challenge in Clinical Research Through Patient Advocacy

HIT Consultant

Andrew Barnhill, Head of Public Policy, Global Legal, IQVIA Alexandra Weiss, Director of Strategic Partnerships, Patient Advocacy Organizations, IQVIA Diversity is paramount to the success of clinical research, both ethically and scientifically.

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Five Public Health Needs for Digital Health Technology

The Digital Health Corner

Digital health technology has seen an incredible growth in the last few years, fueled by a combination of consumerization of wearable technologies, ubiquity of mobile devices, proliferation of technology incubators, attention by government health and regulatory agencies and involvement of large companies heretofore not focused on healthcare.

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TAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year

Health Law Advisor

Food and Drug Administration (FDA) as breakthrough devices. [1] 5] However, devices in earlier stages of the FDA approval process often lack the clinical evidence needed to satisfy the “reasonable and necessary” criteria to justify CMS’s establishment of a national coverage standard.

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