Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.
FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.
FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.
FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).
FDA’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship
Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation
FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.
FDA announces new actions advancing the agency’s biosimilars policy framework
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.
FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder
FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus