KnowHow: The FDB Blog


Health IT Saves Lives in Critical Care│#IHeartHIT

Transformational Change, Information Systems
Friday, October 2, 2015
by Golda Manuel, PharmD, BCPS

In my previous role as a Critical Care Pharmacist, the tenuous nature of a patient’s condition complicates medication therapy. Relying heavily on electronic medical records for medical history, provider progress notes, medication administration times, and so on, I began to paint a picture of this patient. Read More


Medical Devices in a New World│#AdoptUDI

Corporate Perspective, FDA, Government, Transformational Change
Wednesday, September 23, 2015
by Patrick Lupinetti, JD

Today is #adoptUDI day. The next milestone in unique device identifier (UDI) history arrives today, September 24, for Class II implantable/life sustaining/life supporting devices, to be followed next September by the other Class IIs; then by the Class I products in 2018. Read More

Questionable Direction

FDA Direction on Biosimilar Naming Poses More Questions Than Answers

Corporate Perspective, FDA, Government, Standards
Thursday, September 10, 2015
by Tom Bizzaro, RPh & Patrick Lupinetti, JD

On August 27, the Food & Drug Administration (FDA) released draft guidance and a proposed rule on the naming of biologic drugs and biosimilars. Although in agreement in their opposition to the FDA action, FDB’s Tom Bizzaro and Patrick Lupinetti share two perspectives on this controversial issue. Read More

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