Corporate Perspective, Government, Standards
Friday, November 10, 2017
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.
Corporate Perspective, FDA, Government
Tuesday, October 27, 2015
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.
Government, Transformational Change
Monday, October 12, 2015
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.
Corporate Perspective, FDA, Government, Transformational Change
Wednesday, September 23, 2015
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.
Corporate Perspective, FDA, Government, Standards
Thursday, September 10, 2015
On August 27, the Food & Drug Administration (FDA) released draft guidance and a proposed rule on the naming of biologic drugs and biosimilars.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.