Author | Louis A. Morris, PhD

Louis A. Morris, PhD, is a former acting director and branch chief of Divisional Drug Marketing, Advertising, and Communications and has 23 years of FDA experience. He is now president of Louis A. Morris & Associates, a research and consulting firm in Dix Hills, New York.

Articles

The New Era of Risk Management

Pharmaceutical Executive

Article

FDA has issued the industry a new charge-pay closer attention to risk management. Now that prescription drug user fees have helped the agency approve candidates more rapidly, FDA has returned to its basic mandate: assuring that marketed pharmaceuticals are safe. In the past, that meant clear labeling with adequate directions and warnings based on clinical trials. The agency now believes that product safety extends beyond warning labels and wants to ensure that prescriptions are used safely as well. As a result, it is asking the pharma industry to demonstrate products' safety before approval and to further control their use after

Predicting the Federal Game Plan

Pharmaceutical Executive

Article

Yes, there will be a new administration. Yes, there will be changes at FDA. And yes, they will impact drug companies. But predicting what that impact will be is like trying to pick the winner of an NFL game.