Shelley Slade

May 6, 2024 | mlo-online.com | Danielle Casey |Mls Cm |Shelley Slade

The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.

May 2, 2024 | mlo-online.com | Danielle Casey |Mls Cm |Shelley Slade

The U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of healthcare decisions and about which concerns have been raised for many years. The FDA announced a final rule amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.

Apr 22, 2024 | mlo-online.com | Christina Wichmann |Shelley Slade

Molly Broache serves as Associate Director, US Region, Medical Affairs for BD Diagnostic Solutions and is also licensed as a women’s health nurse practitioner in both Maryland and Virginia. Molly manages a team of medical science liaisons responsible for specimen management, microbiology, and women’s health & cancer. Molly’s clinical areas of expertise include women’s healthcare, gynecology, infectious disease diagnostic tests, and women’s health screening guidelines.

Apr 18, 2024 | mlo-online.com | Shelley Slade

The Centers for Medicare and Medicaid Services posted a meeting notice for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel).

Apr 17, 2024 | mlo-online.com | Shelley Slade

The White House released The United States Government Global Health Security Strategy (GHSS) 2024, which acknowledges that the United States and the international community can only achieve global, sustainable health security by working with all countries. The GHSS delineates roles and responsibilities, which are reflective of the CDC’s core capacities. These are to:Implement and coordinate CDC programs to build capacity relevant to health security domestically and globally.