The US House of Representatives on Wednesday unanimously passed two bills that would increase the utility of the US Food and Drug Administration’s (FDA) Orange Book for generic drugmakers and Purple ...
Brandon is a San Antonio based writer with a Bachelors Degree in English. His favorite series is 'The Wheel of Time,' but loves all things Sci-fi Fantasy and Horror. In his free time, expect to find ...
If you purchase an independently reviewed product or service through a link on our website, Rolling Stone may receive an affiliate commission. Amazon has the original Alice Walker novel available for ...
The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product information, known as the Purple Book. Building off the previous ...
In 2021, the FDA’s Purple Book went live, providing a searchable database of licensed biological products, including the patent information provided to biosimilar applicants during the patent dance.
The recently enacted “Purple Book Continuity Act of 2019” went into effect as of June 25, 2021. The FDA must proactively update the Purple Book information every 30 days with an alphabetical list of ...
“Reference biologic drug makers until recently faced no obligation to disclose to the public the patents associated with their licensed biologic products…. This disparity between the Hatch-Waxman and ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results