Reimbursement Shapes FDA Panel’s Dosing Decision For Novartis’ Il-17 Blocker
Executive Summary
Advisory committee swayed by sponsor’s pleas, takes payer practices into account with secukinumab labeling recommendations.
You may also be interested in...
Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length
Recently retired US FDA Principal Deputy Commissioner Janet Woodcock will be advising the Haystack Project, with the goal of helping rare disease organizations encourage creativity in drug development programs without jeopardizing regulatory success, Woodcock told the Pink Sheet in an interview.
Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests
The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions.
Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests
The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions.