Approvals, politics, and user fees are among the issues that make for an uneasy relationship between the US Food and Drug Administration and the life sciences industry, according to findings from a recent PricewaterhouseCoopers (PwC) survey of the industry. This survey, ?Improving America?s Health V,? the fifth such survey performed since 1995, found that although relations between the FDA and the life sciences industry have improved over time, there is still much progress to be made.
In a speech on October 6, 2010, FDA Commissioner Margaret Hamburg outlined the FDA's plan for advancing regulatory science. Her address introduced an FDA document, Advancing Regulatory Science for Public Health, which was released concurrent to her talk.
On July 22, 2010, Sanofi Pasteur (Lyon, France) received a warning letter from the US Food and Drug Administration, citing deviations from current good manufacturing practices (cGMPs) in the manufacture of certain biological products and bulk drug substances, including Imovax Rabies, Imogam Rabies, Ipol, Act HIB, and Typhim Vi.
Merck (Whitehouse Station, NJ) expects that emerging markets will account for more than 25% of its global pharmaceutical and vaccine revenue in 2013, based on the implementation of the company?s emerging markets strategy.