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Category Archives: Safety
The Year to Come: EMA's Plans Announced
At the end of last month, the European Medicines Agency approved its budget and work program for the coming year, promising to implement measures to increase operational efficiency, enhance transparency and communication with stakeholders, and improve the quality and consistency of rulemaking. With a 4.1% increase in budget to €231.6 million and an anticipated 54 [...]
Also posted in Europe, Regulatory, Strategy Tagged EMA, Europe, European Medicines Agency, transparency Leave a comment
New Pseudoephedrine Drug Could Hop Back Over the Counter
Yesterday Acura Pharmaceuticals launched its new pseudoephedrine-based product Nexafed, an over-the-counter product aimed at deterring abuse of the illicit drug methamphetamine. Pseudoephedrine, the decongestant known also as the primary ingredient in the production of methamphetamine, has been subject to a federal statute which keeps medicines with the ingredient behind the counter of all pharmacies in [...]
US v. Caronia: What Constitutes 'Truthful' Speech?
If a drug’s label is not the final word on what is true – or untrue – about a product, then who decides what can and cannot be said during a sales detail?
Also posted in Advertising, FDA, Legal, Marketing, Regulatory, Sales, Strategy, compliance Tagged Alfred Caronia, Appeals Court, Detailing, DoJ, FDA, Federal Trade Commission, FTC, Jazz Pharmaceuticals, Marketing, off-label, Office of Prescription Drug Promotion, Orphan Medical, OTC, Professional Marketing, Promotion, Regulatory, sales rep, Sorrell v. IMS Health, US v. Caronia 1 Comment
Pharma's Reputation: A Boost in the US, but China Strikes a Sour Note
The pharmaceutical industry’s global reputation is on the mend, even if some countries – notably China – are more hostile, according to the latest Ipsos Reputation Snapshot for the Pharmaceutical Sector, from the Ipsos Global Reputation Centre.
Since the last Ipsos survey in 2008, pharma’s reputation has improved significantly in the US, more so than in [...]
Pharma Still Doesn't Get Patient Groups