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Tag Archives: FDA
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?
Posted in Advertising, FDA, Legal, Marketing, Regulatory, Safety, Sales, Strategy, compliance Also tagged Alfred Caronia, Appeals Court, Detailing, DoJ, 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
Pipeline Report Preview
Posted in Advertising, Biotech, Europe, FDA, Gene therapy, Global, IP, R&D, Regulatory, Strategy, Video Also tagged business, Eli Lilly, Europe, Merck, Pfizer, pipeline, R&D, Strategy, United States Leave a comment
FDA Already Knew of Problems at New England Compounding Center
By Amy Ritter.
In the wake of the meningitis outbreak caused by contaminated compounded medications produced by the New England Compounding Center (NECC), both the government and the public have been wrestling with the question of how this happened — how did a company producing substandard medicines slip through regulatory oversight?
Posted in Guest Blog, Regulatory Also tagged House Energy and Commerce Committee, NECC, New England Compunding Center Leave a comment
Ethics in Drug Innovation: The First Hurdle is Trust
By Ansis Helmanis
Ethics is a matter of trust, which in the regulatory space requires transparency and openness among all stakeholders, including patients and industry. This was the consensus of FDA Commissioner Margaret Hamburg and European Medicines Agency (EMA) Executive Director Guido Rasi, both of whom shared the podium with Nobel Laureate Professor Elie Wiesel [...]
Posted in Europe, Events, FDA, Global, Guest Blog, Market Access, Patient Communication, Regulatory, healthcare, leadership, pricing Also tagged CMS, Elie Wiesel, EMA, Guido Rasi, Margaret Hamburg, Prix Galien, reimbursement, sequestration Leave a comment
Will "Robust Pipeline" Yield More New Drugs?