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FDA Announces Measure to Ease Patient Access to Investigational Drugs
In his blog post on FDAVoice, Peter Lurie MD, MPH, associate FDA commissioner for public health strategy and analysis, announced the introduction of a draft form and a draft guideline that can be used by a physician to request access to an experimental drug or biological product that is still under development.
Today, I had the pleasure of announcing an important measure intended to help streamline expanded access to investigational drugs. We heard concerns from patients and physicians that the process for gaining access to investigational drugs was too difficult, and pulled together a team to find a way to make that process simpler.
Today, we’re introducing a much simpler draft form for comment that, when finalized, should accelerate patient access to investigational drugs. We know what an important tool this will be for physicians who treat those patients with serious or immediately life-threatening diseases or conditions for which there are no comparable alternative treatments.
Link to the blog post on the FDA website: http://1.usa.gov/1BUwo6R
Standard Criteria for Loss of Ambulation Needed in DMD
April 19th 2024A recent study suggests the differences between ambulation definitions for patients with Duchenne muscular dystrophy (DMD) can impact the identification of ambulant vs nonambulant individuals, and standard criteria across settings are needed.
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Navigating Health Literacy, Social Determinants, and Discrimination in National Health Plans
February 13th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the February 2024 issue of The American Journal of Managed Care® about their findings on how health plans can screen for health literacy, social determinants of health, and perceived health care discrimination.
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An Overview of Health Care and Pharmaceutical Trends, 2023-2024
April 19th 2024Douglas M. Long, BA, MBA, was featured as the keynote speaker on the closing day of The Academy of Managed Care Pharmacy 2024 annual meeting, with a session dedicated to surveying the health care and pharmaceutical trends of the last year.
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Drs Raymond Thertulien, Joseph Mikhael on Racial Disparities in Multiple Myeloma Care Access
December 28th 2023In the wake of the 2023 American Society of Hematology Annual Meeting and Exposition, Raymond Thertulien, MD, PhD, of Novant Health, and Joseph Mikhael, MD, MEd, FRCPC, FACP, chief medical officer of the International Myeloma Foundation, discussed health equity research highlights from the meeting and drivers of racial disparities in multiple myeloma outcomes.
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Real-World Study Reveals Key Insights Into DLBCL Treatment Patterns, Outcomes
April 18th 2024A recent study offers valuable insights into the characteristics, treatment patterns, and outcomes of diffuse large B-cell lymphoma (DLBCL) in patients across different lines of therapy, providing a look into the landscape of DLBCL management.
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