Category Archives: compliance

Gov't Shutdown Halts FDA Product Submissions and Other Functions

Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown. Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that […]
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FTC Concerned About Increase in "Sponsored Content"

The blurring of advertising and editorial content, particularly through publishers’ websites and mobile applications, is in the spotlight at the Federal Trade Commission (FTC) as government regulators struggle to deal with the impact of social media on health-related promotion. The Commission’s long-held policy is that advertising and sales pitches should be readily identified and not […]
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The Sunshine Act Makes for Gloomy Sales Reps

On Café Pharma message boards, the drug industry’s online water cooler, anonymous sales reps are sounding off on the Physician Payment Sunshine Act and its implications for their battered profession. Here’s a selection from a thread that PharmExec came across, edited for spelling, punctuation, and coherence:
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How to Win in the Diabetes Space

Novo Nordisk’s SVP of national diabetes sales speaks with PharmExec about a new field force technology initiative, implications of the Sunshine Act, and why Victoza sales won’t slow down anytime soon. At a time when meaningful growth at most big pharma companies is happening in emerging markets – and nowhere else – Novo’s 2Q earnings […]
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Promotional Review Committees: Shire Sets the Standard on Achieving High Performing Teams

by Arthur Lazarus What does it take for internal Promotional Review Committees to function at their best and avoid costly mistakes to the company? A leading industry practitioner offers 15 tips for high performing teams. Arthur Lazarus, MD, MBA, Shire Pharmaceuticals 1. Find a common voice. Given the diverse training and background of individuals who […]
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