Why Protecting Confidential Information is Key to the FDA’s "Gold Standard"

https://www.fda.gov/news-events/fda-voices/why-protecting-confidential-information-key-fdas-gold-standard?utm_medium=email&utm_source=govdelivery When Americans look to the U.S. Food and Drug Administration, they are expecting to see the "Gold Standard" of regulatory review—the rigorous scientific scrutiny that determines whether a new therapy, medical device, or food process is safe and effective. Behind every one of these critical decisions lies one of the world’s most sensitive repositories of intellectual property and personal data. In an era defined by radical transparency, the FDA operates at a unique crossroads. As public servants, the staff of the FDA are driven by the principle that the American people deserve openness regarding decisions that affect their health. The FDA remains committed to evolving policies that aim for more transparency and taking steps to support innovation through greater transparency and predictability. At the same time, the integrity of that very process—and the life-saving innovation we oversee—depends on the agency’s ability to act as a fortress for the sensitive information entrusted to us.