KnowHow: The FDB Blog

FDA's Biosimilar ID Requirements Fly in the Face of Cost-Cutting Aspirations

Corporate Perspective, Government, Standards
Friday, November 10, 2017 by Tom Bizzaro, RPh

Curiously, the FDA seems to be undercutting its own cost savings efforts through its support of a rule that would require unique non-proprietary names with four-character suffixes for biosimilar products. The problem is this proposed naming convention is simply not necessary and could do more harm than good. Read more...

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Why Does FDA Approval Matter?

Corporate Perspective, FDA, Government
Tuesday, October 27, 2015 by Reem Mohamed, PharmD

For our second blog in our column "Little Known Facts About Drugs," I wanted to review the compelling history of the FDA approval process, as I am not sure how many readers are familiar with the tragic circumstances that led to the development of the Food, Drugs and Cosmetics Act. Read more...

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Drug Warning Labels

An Overview of California's New Multi-Language Prescription Drug Labels Law

Government, Transformational Change
Monday, October 12, 2015 by Sims Preston

On October 11, California Governor Jerry Brown signed into law AB 1073, which will require pharmacists – and pretty much anyone else dispensing drugs in the state – to provide medication instructions in certain non-English languages when requested by patients.

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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...

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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On August 27, the Food & Drug Administration (FDA) released draft guidance and a proposed rule on the naming of biologic drugs and biosimilars.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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