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Judge Likely To Order Lower Age Restriction For Emergency Contraceptives

 
• By Brenda Sandburg

A federal judge seems inclined to order FDA to make emergency contraceptives available OTC to women younger than 17, but he did not say whether the use would be limited to Teva’s Plan B One-Step, or would include all nonprescription levonorgestrel products.

A federal judge indicated he may order FDA to make the emergency contraceptive levonorgestrel available nonprescription to women younger than 17.

In U.S. District Court for the Eastern District of New York, Judge Edward Korman said he might revise his 2009...

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‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By Sue Sutter

Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.

US FDA Chief Counsel Position Awaits HHS General Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 
• By Francesca Bruce

European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.