FDA calls for comments: biosimilar interchangeability

February 5, 2015 12:00 PM

The Food and Drug Administration (FDA) has announced an opportunity for public comment on the proposed collection of certain information by the Agency.

The notice sent by the US FDA solicits comments on the information collection in an application for a proposed biosimilar product and an application for a supplement for a proposed interchangeable product.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The document can be found on Federal Register and companies should submit either electronic or written comments on the collection of information by April 6, 2015.

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)


Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?

Suggestions?

Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!