Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 126: Josh Arant, COO, Mako Medical
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more
On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more
On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the agency recognizes that completion of laboratory...more
As the coronavirus outbreak continues to wreak havoc on markets and industries in the U.S. and around the world, businesses are now confronting significant and unique challenges. Successful navigation of these challenges...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
On February 21, 2020, the Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: The Scope and Significance of Progress in 2019” (Report) that monitors FDA approvals of precision medicine...more
Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more
According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more
On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more
The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more
On May 28, 2015, the OIG published a revised version of its Work Plan for Fiscal Year (FY) 2015. As previously reported, the original version of the FY 2015 Work Plan was published in October and summarized the OIG's ongoing...more