Day: January 18, 2018

In his response to a GAO report that FDA needs to evaluate appropriate implementation of the least burdensome requirements of the 21st Century Cures Act, the FDA Commissioner announced that FDA has already trained more than 90 percent of its reviewers in CDRH in least burdensome requirements for new medical device approval decisions, and that … Read more

FDA is working on new rules to require a simplified one-page Medication Guide for prescription drugs to supplement the longer package inserts that usually accompany a drug to make it easier for the patients to understand their medication. Earlier this week FDA announced its major policy goals for this year and it contains several things … Read more