EMA Moves To Reassure Europe Over Combined Contraceptives
This article was originally published in The Pink Sheet Daily
Executive Summary
EMA says there is currently no cause for concern, amid increasing claims in Europe’s media that combined contraceptives can cause blood clots.
You may also be interested in...
EMA Birth Control Safety Review Shows PRAC’s Clout, Concern About Newer Products
The Pharmacovigilance Risk Assessment Committee is assessing whether use of third- and fourth-generation combined oral contraceptives should be limited to women who cannot take other birth control pills; this is the ninth group of drugs PRAC has been asked to review.
Oral Contraceptives Petition Seeking Ban On Third-Generation Products Denied By FDA
Public Citizen losses again as the agency says current product labeling for desogestrel-containing oral contraceptives adequately describes the risk of venous thromboembolism; FDA notes the difficulty in comparing the magnitude of risks between combination OCs.
Surprise Device Inspections, And More, Coming Soon To The EU
It will be years before the device and diagnostic regulations proposed last month by the European Commission take effect, but policymakers are pressing forward to implement select reforms, including surprise facility inspections, on an interim basis by early next year.