Oral Contraceptive Switch Advocates Reject User Age As Approval Factor
This article was originally published in The Pink Sheet
Executive Summary
FDA could soon receive an NDA from non-profit research group Ibis Reproductive Health and HRA Pharma, for an oral contraceptive switch in the US.
You may also be interested in...
HHS Plan To Exempt Employers From Birth-Control Mandate Threatens IUD Sales
An HHS draft proposal to broaden the "religious and moral objections" exemption from an Affordable Care Act rule mandating that employers cover employees' contraceptive use in health care plans, threatens US sales of intrauterine devices (IUDs), which total more than $1bn annually.
FDA Drops Access Restrictions On Generic OTC Emergency Contraceptives
In a recent letter to drug firms, FDA rejects Plan B One-Step manufacturer Teva’s requests to restrict sales and labeling of generic equivalents. Labeling for the generics will not prevent consumers under 17 from buying the products nor require retailers to ask consumers for proof of age.
Jurors' Answers In FTC's Prevagen Complaint Might Burst A Memory Bubble For Health Claims
“No” answers in New York federal court on whether all but two of Prevagen claims were “materially misleading” could put a fork in the road of a long dispute between FTC and supplement product manufacturers and marketers.