FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for...16 March 2016
If you missed the Maximizing Patent Life Cycles panel discussion, you may want to read this
It also published the article “ANDA Changes May Require Paragraph IV Recertification, New 30-Month Stay,” which includes my comments from the event on the trend in the amending of generic drug applications to adjust to developments in ongoing patent litigation.
The Generic Pharmaceutical Association requests that the U.S. Food and Drug Administration assign the same non-proprietary name to a biosimilar as the one held by its reference biologic....26 September 2013
A collection of associations for higher education wrote to FDA Commissioner Margaret Hamburg urging a requirement for biosimilar applicants to certify that they have complied with the...14 November 2012