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FDA Lull In Rx Promotion Citations Continues; Guidances May Be Bigger Priority

 
• By Brenda Sandburg

Even with recent letters, Office of Prescription Drug Promotion’s slow pace continues from 2014’s record low.

FDA’s Office of Prescription Drug Promotion’s workload is getting lighter in one area: it is finding fewer objectionable promotional pieces. This year the office has issued only two letters to drug sponsors for making inappropriate claims about their products.

The low number of enforcement letters continues a downward trend since the agency’s record high of 51 letters in 2010....

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Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
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EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
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Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
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An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

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Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 
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EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

 
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Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.