Here are four points:
1. During his tenure, Dr. Califf has supported the association’s mandate that drugs must demonstrate effectiveness to receive approval. Nearly 90 percent of drugs accepted into Phase One never see the market, due to reasons like toxicity or ineffectiveness.
2. He noted information technology will continue to be at the forefront of the agency’s mind, with a focus on hiring skilled professionals and developing infrastructure.
3. Dr. Califf said backing up their regulatory decisions with solid evidence also proves critical. Overwhelmed with information, Dr. Califf noted, “as a society we haven’t been so good at turning that information into knowledge.”
4. He said the agency is pleased with the 21st Century Cures Act and believes it aligns with their mission.
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