Tag Archives: FDA
By Jill Wechsler | Published: January 21, 2013
Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies. A report by the Analysis Group for the Pharmaceutical Research and Manufacturers of America (PhRMA) documents more than 5,000 new medicines in [...]
By Ben Comer | Published: December 5, 2012
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?
By Guest Blogger | Published: November 14, 2012
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?
By Guest Blogger | Published: October 19, 2012
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 [...]