Wyeth Loses Citizen Petition Battle But Wins War Over Compounded Hormones
Executive Summary
Wyeth will probably be satisfied by FDA's response to its citizen petition appealing for regulatory action against pharmacies distributing compounded hormone replacement therapy products. Although the agency denied the bulk of Wyeth's petition, FDA took action against compounding pharmacies for several related violations
You may also be interested in...
Compounding Bill In Senate Gets Bipartisan Push For Floor Vote
HELP Committee leaders Harkin and Alexander write letter arguing that FDA’s warnings of more problems from tainted compounded medications have come true and that their legislation should gain a vote next month.
FDA Steps Into Makena Pricing Dispute In The Name Of "Access"
FDA is citing patient access as the reason behind its unusual decision to insert itself in the middle of a pricing debate involving KV Pharmaceuticals’ pre-term delivery drug Makena.
FDA Steps Into Makena Pricing Dispute In The Name Of "Access"
FDA is citing patient access as the reason behind its unusual decision to insert itself in the middle of a pricing debate involving KV Pharmaceuticals’ pre-term delivery drug Makena.