By Creating A More Effective, Efficient FDA Author: Karl A. DeSante
Without question, one of the most important endeavors facing the United States pharmaceutical industry is reforming the drug-review process at the Food and Drug Administration (FDA). Changes to help streamline the regulatory process can help ensure financial underpinning for ongoing research and innovation, and decrease the cost of medications while increasing the speed with which effective new drugs reach physicians and patients.
These benefits of accelerating drug discovery and development are significant, and my colleagues at the American Association of Pharmaceutical Scientists (AAPS) and I feel it is time for scientists to come together to lay the groundwork for reform in order to help the FDA help itself.
With all of the changes that need to be made, however, the agency's paramount objective should always remain to protect the public health. Reform should speed up the regulatory process without...