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Consumer Healthcare Products Association

Keeping Score In Drug Development And Innovation Game? Look To US FDA As The Referee – Califf

 
• By Malcolm Spicer

“It's really the elected officials who are making the final determination on what happens. They're really the owners of the teams, you guys in the industry are playing the game we’re refereeing,” FDA Commissioner Robert Califf says at Consumer Healthcare Products Association conference.

Potential Action By US FDA On Oral Phenylephrine ‘A Lot Harder’ With Old Monograph Program

 
• By Malcolm Spicer

“We've had several citizen petitions. We can't ignore the data that are out there and are very new since the last time FDA had looked at this back in 2007,” says FDA OTC drugs office director Theresa Michele.